Identifiers
- 510(k) Number
- K192234 FDA 510(k)
- FDA Product Code
- PQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5290 FDA 510(k)
- Regulation Number
- 890.5290 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ActiPatch is a nonthermal shortwave therapy device indicated for over-the-counter use for the treatment of pain. It is designed to provide pain relief for various conditions.
The device is supplied as a Class II medical device with FDA 510(k) clearance under product code PQY. It is intended for over-the-counter use and should be used according to the manufacturer's instructions.
Frequently asked questions
What is ActiPatch used for?
ActiPatch is a nonthermal shortwave therapy device indicated for over-the-counter use for the treatment of pain. It is designed to provide pain relief for various conditions.
How is ActiPatch supplied?
ActiPatch is supplied as a Class II medical device with FDA 510(k) clearance under product code PQY. It is intended for over-the-counter use and should be used according to the manufacturer's instructions.
What is the regulatory status of ActiPatch?
ActiPatch has FDA 510(k) clearance under product code PQY. It is classified as a Class II medical device and is intended for over-the-counter use.
Is ActiPatch a single-use or reusable device?
The device data does not specify whether ActiPatch is single-use or reusable. Users should refer to the manufacturer's instructions for proper usage and disposal guidelines.
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: ActiPatch® - BioElectronics Corporation, BioElectronics Corporation, BioElectronics Corporation - Changing the way people heal & stop pain, CLINICAL EVIDENCE - BioElectronics Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192234 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioelectronics Corporation
Sources (1)
- FDA 510(k) K192234 24 fields · synced Sep 19, 2026