PQY — Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain Class II
FDA product code PQY covers "Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain", a Class II medical device regulated under 21 CFR 890.5290. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PQY
- Device Class
- Class II
- Regulation Number
- 890.5290
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.