Identifiers
- 510(k) Number
- K181497 FDA 510(k)
- FDA Product Code
- KPI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5320 FDA 510(k)
- Regulation Number
- 876.5320 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HPM-6000UF is a non-implantable electrical stimulator designed for incontinence. It functions as a non-implanted electrical continence device.
This device is classified as a Class II medical device under regulation number 876.5320. It has received FDA 510(k) clearance under the product code KPI.
Frequently asked questions
What is the primary function of the HPM-6000UF?
The HPM-6000UF is a non-implantable electrical stimulator specifically designed to assist in the management of incontinence by acting as a non-implanted electrical continence device.
What is the regulatory classification of this device?
The HPM-6000UF is classified as a Class II medical device under regulation number 876.5320. It has received FDA 510(k) clearance under product code KPI, indicating it has been found substantially equivalent to legally marketed predicate devices.
Which medical specialty oversees this device?
The device is categorized under the Gastroenterology and Urology advisory committees, reflecting its intended use for continence management within these clinical fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF November 14, 2018 David Chmel VP of Operations Trade/Device Name: HPM ..., HPM-6000UF (K181497) — FDA 510(k) | Innolitics, HPM-6000UF 510 (k) K181497 - FDA.report, K181497 FDA 510 (k) - HPM-6000UF | BTL Industries, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181497 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BTL Industries, Inc.
Sources (1)
- FDA 510(k) K181497 24 fields · synced Sep 24, 2026