BTL-299-F— 510(k) K262353
Substantially EquivalentBTL Industries, Inc.
FDA 510(k) clearance K262353 for BTL-299-F, Substantially Equivalent on 2026-09-23. Applicant: BTL Industries, Inc.. Device class: 2.
Summary
BTL-299-F is identified in the record only by its model number. The product code, KPI, covers non-implantable electrical stimulators for incontinence, so that's the category. The record doesn't describe the device's form or how it delivers stimulation.
Class II, 21 CFR 876.5320. The Gastroenterology and Urology panel reviewed it as a Traditional 510(k).
BTL Industries, Inc. filed from Marlborough, Massachusetts. Review took 75 days (July 10 to September 23, 2026).
Clearance details
- Applicant
- BTL Industries, Inc.
- Product code
- Product code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
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- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
More clearances from BTL Industries, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.