K192234 is an FDA 510(k) clearance for the ActiPatch. This device is classified as a Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain (Class II - Special Controls, product code PQY).
Submitted by Bioelectronics Corporation (Frederick, US). The FDA issued a Cleared decision on January 31, 2020, 165 days after receiving the submission on August 19, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290. Nonthermal Pulsed Electromagnetic Energy Intended For Over-the-counter Use For The Treatment Of Pain..
| 510(k) Number | K192234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2019 |
| Decision Date | January 31, 2020 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | PQY - Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |
| Definition | Nonthermal Pulsed Electromagnetic Energy Intended For Over-the-counter Use For The Treatment Of Pain. |