ActiPatch 088
by Bioelectronics Corporation 10 variants
ActiPatch 088 (103-4), a hand-held deep-tissue electromagnetic stimulator (FDA Class II; FDA product code PQY) made by Bioelectronics Corporation, was cleared under FDA 510(k) K152432 on 3 Feb 2017 and listed in FDA GUDID on 23 Jul 2020 (UDI-DI 00851329005012); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851329005012 | Date23 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152432 | Date3 Feb 2017 | StatusActive |
Official records
- AccessGUDID record 00851329005012
- FDA 510(k) database K152432
Across registries
- FDA 510(k) K152432 decided 3 Feb 2017 Active
- FDA GUDID UDI-DI 00851329005012 listed 23 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K152432
- Listed FDA GUDID 00851329005012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ActiPatch
- Generic name
- Hand-held deep-tissue electromagnetic stimulator
- Model / Ref / Catalog
- 088, 103-4
- Primary DI / UDI-DI
- 00851329005012
- 510(k) Number
- FDA product code
- PQY
- GMDN term
- Hand-held deep-tissue electromagnetic stimulator
- Device class
- Class II
- Regulation number
- 890.5290
- GUDID distribution status
- Not in Commercial Distribution