← FDA Medical Device Classifications
Electromagnetic Stimulator, Pain Relief
QPL · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5890
Classification
- FDA Product Code
QPL- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 882.5890
- Review panel
- PM
- Medical specialty
- Neurology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Intended to apply a magnetic-field induced electrical current to treat pain.
Market data
- Cleared 510(k) submissions
- 6
- Registered establishments
- 7
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown