PQY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Medical specialty
- Physical Medicine
- FDA definition
- Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ActiPatch (K192234) | Bioelectronics Corporation | 2020-01-31 |
| ActiPatch(R) (K152432) | Bioelectronics Corporation | 2017-02-03 |
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Every clearance here is in the API, with alerts when new ones post.