Research report
A research report is the sourced material a domain
dossier is synthesized from — generated on a plan and a cadence, one topic per file.
A report carries no confidence tags. Its bracketed markers say who might have
an incentive to shade a line; none of them says anyone checked it. To reach a score, a line has
to be drafted onto a candidate as unverified and pass the Verifier or the
Corroborator, like everything else.
Section market-players · Version 2026-09-01 · Cadence monthly · Evidence class 1 registry · Sources 14 · Supersedes none
Domain: stress-urinary-incontinence · Scope: Public primary sources reachable by this repo's connectors (openFDA 510(k), recall and classification endpoints; ClinicalTrials.gov), WebSearch and WebFetch. Excludes MAUDE complaint narratives (no connector in this repo), the FDA De Novo listing beyond what openFDA's 510(k) index itself surfaces (no local cache at data/fda_denovo.csv), company financial filings and SEC EDGAR accession numbers (do not satisfy this fleet's identifier vocabulary), CPT descriptors (AMA-licensed), and any jurisdiction outside the US.
Sourcing: FDA 510(k), recall and device-classification records across three product codes, independently retrieved this pass by product-code- and firm-scoped connector queries, plus one ClinicalTrials.gov registration; two reported corporate acquisitions were located by WebSearch but carry no resolvable registry identifier and are named, not cited, in section 5.
Commercially cleared SUI devices sit under three FDA product codes with three different market shapes. Over the decade to 2026-09-02, FDA cleared 31 nonimplanted-electrical-stimulator (KPI) devices from at least 21 distinct applicant firms, 5 transcutaneous-stimulator (QAJ) devices from exactly two firms, and 16 perineometer/biofeedback-trainer (HIR) devices from at least 13 firms [1][2][3]. KPI entrants from 2024 onward are dominated by first-time, China-based contract manufacturers, a compositional shift the raw clearance count alone does not show. Neither KPI nor QAJ carries a recorded FDA device recall over the same window; HIR carries exactly one, against an uncleared product sold by a firm that separately holds a legitimate clearance for a different device [4][5]. The HIR code also answers an open question this domain's dossier left unresolved: Perifit (X6 Innovations) holds two FDA clearances explicitly indicated for stress urinary incontinence treatment [6]. Two named incumbents — Atlantic Therapeutics (INNOVO) and Renovia (leva) — were reported by WebSearch to have changed ownership in 2023 and 2025 respectively, but neither transaction carries a federal-registry identifier this report can cite as a source.
_Baseline (v1). No prior version; this establishes the starting point for future diffs._
FDA recorded 31 KPI 510(k) clearances in the ten years to 2026-09-02, spanning at least 21 distinct applicant firms; only six filed more than once — Shenzhen Konmed Technology Co., Ltd. (four clearances, 2018–2026), and BTL Industries, Well-Life Healthcare, Zmi Electronics, Tenscare and Everyway Medical Instruments (two each) [1]. The clearance pace accelerated inside the window: roughly three per year from 2021 through 2023, versus six in the first half of 2026 alone, through the most recent record located, K260178 (Shenzhen Konmed, decided 2026-06-18) [1]. A finding this report adds to what the domain's dossier already tracks for InControl Medical: beyond the three InTone-family clearances (K133826, K134020, K150180) the dossier names, InControl Medical holds a fourth KPI clearance, ApexMV (K182022, decided 2019-03-15), indicated for "stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women" [7].
All five QAJ clearances in the decade belong to two firms. Elidah, Inc. holds three: ELITONE for stress incontinence (K183585, 2019), ELITONE Urge (K223884, 2023), and, newest, "Elitone for Men" (K253285, decided 2026-01-23), indicated to "aid early continence recovery in men immediately following prostate surgery" — a population and indication not previously named for this product line [8][9]. Atlantic Therapeutics holds the other two, INNOVO (K192357, decided 2020-01-16) and its predecessor De Novo-pathway record (DEN170049, 2018) [10]. No third firm has entered this product code in the window searched.
Sixteen HIR clearances span at least 13 firms, mixing app-connected biofeedback trainers with simple mechanical resistive devices. Renovia, Inc. filed four leva-branded clearances between 2018 and 2022 (K180637, K192270, K212495, K213913), the last indicated for "strengthening of the pelvic floor muscles" and "rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence" via a smartphone-connected probe [11]. Pelvital USA, Inc. filed three Flyte-branded clearances (K210764, K212655, K233362, plus a fourth, K240805, decided 2024-08-01, "intended for strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence") [12]. Most directly relevant to this domain's own dossier: X6 Innovations holds two clearances, Perifit (K221476, 2023-02-10) and Perifit Care+ (K231780, 2023-12-20), both indicated to "treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise" with smartphone biofeedback — this is the "undiscovered pelvic-floor clearance under a different device name" the dossier's market-players section named as an open question for Perifit, now answered [6].
FDA recorded zero device recalls under either KPI or QAJ in the ten years searched [4]. HIR carries exactly one: Ralston Group's "Maximum Pelvic Trainer (MPT)," recall initiated 2019-07-12, stated reason "the device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device" [5]. The same firm's actually-cleared device, the Feminine Personal Trainer (K171896, decided 2017-08-29), is a separate, unrelated product [13]. Read narrowly: this is a listing/clearance failure for one uncleared product line, not a stated safety or performance defect in any device that did clear.
BTL Industries' Emsella chair, a magnetic-stimulation SUI product marketed commercially, is the subject of an independent, non-industry-sponsored sham-controlled trial run by Corewell Health East (NCT04133675, record last updated 2026-07-09, status RECRUITING) [14]. A direct device-name search of the FDA 510(k) index for "Emsella" returned no record, so its US clearance basis, if any, sits outside the KPI/QAJ/HIR codes surveyed here and was not traced further this pass.
[1] openFDA device/510k scan, product_code=KPI, decision window 2016-09-04 to 2026-09-02 — FDA (queried 2026-09-01; accessed 2026-09-01). 31 records; most recent K260178 — https://api.fda.gov/device/510k.json?search=product_code:KPI [federal-registry] [2] openFDA device/510k scan, product_code=QAJ, decision window 2016-09-04 to 2026-09-02 — FDA (queried 2026-09-01; accessed 2026-09-01). 5 records; most recent K253285 — https://api.fda.gov/device/510k.json?search=product_code:QAJ [federal-registry] [3] openFDA device/510k scan, product_code=HIR, decision window 2016-09-04 to 2026-09-02 — FDA (queried 2026-09-01; accessed 2026-09-01). 16 records; most recent K252748 — https://api.fda.gov/device/510k.json?search=product_code:HIR [federal-registry] [4] openFDA device/recall scan, product_code=KPI and product_code=QAJ, event-date window 2016-09-04 to 2026-09-02 — FDA (queried 2026-09-01; accessed 2026-09-01). Zero records either code. 21 CFR 876.5320 — https://api.fda.gov/device/recall.json?search=product_code:KPI [federal-registry] [5] Device recall Z-2087-2019 — Ralston Group, Maximum Pelvic Trainer (MPT) — FDA (recall initiated 2019-07-12, status Terminated; accessed 2026-09-01). Z-2087-2019 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [6] 510(k)s K221476 / K231780 — Perifit / Perifit Care+, X6 Innovations — FDA (decided 2023-02-10 / 2023-12-20; accessed 2026-09-01). K221476 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221476 [federal-registry] [7] 510(k) K182022 — ApexMV, Incontrol Medical, LLC — FDA (decided 2019-03-15; accessed 2026-09-01). K182022 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182022 [federal-registry] [8] 510(k) K253285 — Elitone for Men, Elidah, Inc. — FDA (decided 2026-01-23; accessed 2026-09-01). K253285 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253285 [federal-registry] [9] 510(k)s K183585 / K223884 — Elitone Device / ELITONE Urge Urinary Incontinence Device, Elidah, Inc. — FDA (decided 2019-02-11 / 2023-02-24; accessed 2026-09-01). K183585 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183585 [federal-registry] [10] 510(k) K192357 and DEN170049 — INNOVO, Atlantic Therapeutics, Ltd. / Bio-Medical Research, Ltd. — FDA (decided 2020-01-16 / 2018-11-06; accessed 2026-09-01). K192357 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192357 [federal-registry] [11] 510(k)s K180637 / K192270 / K212495 / K213913 — leva Pelvic Floor Trainer / LEva Pelvic Digital Health System / Leva Pelvic Health System, Renovia, Inc. — FDA (decided 2018-04-04 / 2019-11-22 / 2021-09-08 / 2022-06-30; accessed 2026-09-01). K213913 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213913 [federal-registry] [12] 510(k)s K210764 / K212655 / K233362 / K240805 — Flyte / Flyte Mechanotherapy System, Pelvital USA, Inc. — FDA (decided 2021-04-13 / 2021-09-21 / 2023-12-29 / 2024-08-01; accessed 2026-09-01). K240805 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240805 [federal-registry] [13] 510(k) K171896 — Feminine Personal Trainer (FPT) / NatraTone, Ralston Group — FDA (decided 2017-08-29; accessed 2026-09-01). K171896 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171896 [federal-registry] [14] NCT04133675 — "BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence," ClinicalTrials.gov, sponsor Corewell Health East (record last updated 2026-07-09, status RECRUITING; accessed 2026-09-01). NCT04133675 — https://clinicaltrials.gov/study/NCT04133675 [trial-registry]
Well established: the product-code-level clearance counts and their distinct-applicant tallies for KPI, QAJ and HIR rest on direct, unfiltered openFDA 510(k) queries, none truncated [1][2][3]. The zero-recall record for KPI and QAJ, and the single HIR recall and its stated reason, rest on direct, unfiltered openFDA recall queries [4][5]. Perifit's and Perifit Care+'s SUI indication rests on the FDA 510(k) summary's own verbatim Indications for Use text, not a secondary description [6].
Thin: the characterization of 2024–2026 KPI entrants as predominantly first-time, China-based contract manufacturers rests on applicant names and addresses as they appear in the openFDA record itself, not on an independently confirmed corporate registry for each firm — treated here as a direct reading of the primary record rather than a directional source, so no marker is attached, but no second source corroborates any individual firm's country of incorporation.
Rescoped from class 3: "which companies will dominate this market" has no answerable form. Its twin — which firms have actually filed a 510(k) or drawn a recall in the three product codes underlying this domain, over the last decade — is what section 3 answers, and it is registry- checkable rather than a forecast.
Out of scope: CPT descriptors (AMA-licensed). MAUDE complaint narratives for any named device (no connector in this repo). Company financial filings and SEC EDGAR accession numbers — no connector reaches these, and per this fleet's identifier vocabulary an accession number does not resolve as an identifier. Non-US clearance, recall or funding activity for any firm named (no connector in this repo queries a non-US registry).
Not searched vs. not found: Not found — an FDA 510(k) record under the device name "Emsella" (a direct device-name search returned none; BTL Industries' other KPI-coded clearances, HPM-6000U K162010 and BTL-398 K241516, are separate device names and were not treated as equivalent to Emsella) [14]. Not searched — FDA Establishment Registration & Device Listing records for any firm named (no connector in this repo reaches this dataset), which would be the closest primary route to tracing which entity currently operates a given clearance after a reported acquisition. Found but not citable under this fleet's identifier vocabulary — WebSearch located reports that Caldera Medical completed an acquisition of Atlantic Therapeutics (maker of INNOVO, QAJ) in September 2023, and that Renovia, Inc. (maker of leva, HIR) ceased operating in 2025 with the leva product line acquired by Axena Health, which separately raised reported funding. Neither is entered as a numbered source: no company press release, news article, or investor announcement found for either transaction carries a PMID, NCT number, K-number, recall number, CFR section, HCPCS code, DOI, CELEX number, or Federal Register document number, and openFDA's own 510(k) index was checked and shows no new clearance filed under either Caldera Medical's or Axena Health's name for the relevant product codes as of this pass — an acquisition of an existing corporate entity does not require a new 510(k), so the registry's silence here is not itself evidence either way.
[inference] Reading the KPI code's 2024–2026 entrant wave as an offshore-manufacturer supply response to an accelerating clearance pace, rather than a wave of clinically differentiated products, is this report's own synthesis of the applicant list in section 3; no cited source characterizes the wave that way directly.
| Proposition | Evidence class | Resolvable identifier | Dossier section |
|---|---|---|---|
| FDA cleared 31 510(k)s under product code KPI between 2016-09-04 and 2026-09-02, spanning at least 21 distinct applicant firms | 1 registry | K260178 | 8 Market players & dynamics |
| Only two firms, Elidah, Inc. and Atlantic Therapeutics, Ltd., have ever held a 510(k) clearance under product code QAJ | 1 registry | K253285 | 8 Market players & dynamics |
| InControl Medical, LLC holds a fourth KPI clearance, ApexMV (K182022, decided 2019-03-15), beyond the three InTone-family clearances already on record in this domain | 1 registry | K182022 | 8 Market players & dynamics |
| X6 Innovations' Perifit (K221476) and Perifit Care+ (K231780) are both cleared under product code HIR with indications explicitly naming stress urinary incontinence treatment | 1 registry | K221476 | 8 Market players & dynamics |
| FDA recorded a 2019 recall of Ralston Group's Maximum Pelvic Trainer because the device was marketed without a submitted 510(k) | 1 registry | Z-2087-2019 | 8 Market players & dynamics |
| Elidah, Inc.'s third QAJ clearance, Elitone for Men (K253285, decided 2026-01-23), extends the ELITONE line to post-prostatectomy male incontinence | 1 registry | K253285 | 8 Market players & dynamics |