← FDA Medical Device Classifications
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
PQY · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5290
Classification
- FDA Product Code
PQY- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 890.5290
- Review panel
- PM
- Medical specialty
- Physical Medicine
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 4
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown