ActiPatch(R)
510(k) K152432
ActiPatch(R) is a medical device (FDA Class II; FDA product code PQY) made by Bioelectronics Corporation, cleared under FDA 510(k) K152432 on 3 Feb 2017, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152432 | Date3 Feb 2017 | StatusActive |
Official records
- FDA 510(k) database K152432
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PQY
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5290
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K152432
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ActiPatch 077 | 168 / 077 | 00851329005203 | — | On the market |
| ActiPatch 088 | 090-4 / 088 | 00851329005159 | — | No longer on the market |
| ActiPatch 088 | 103-4 / 088 | 00851329005012 | — | No longer on the market |