ActiPatch
FDA 510(k) clearance K192234 · decided 2020-01-31
Clearance details
- K-number
- K192234
- Device name
- ActiPatch
- Applicant
- Bioelectronics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-08-19
- Decision date
- 2020-01-31
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- PQY
- Device class
- 2
- Regulation number
- 890.5290
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Frederick, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ActiPatch(R) (K152432) | Bioelectronics Corporation | 2017-02-03 |
Recalls involving this device
No recalls on record reference this clearance.