← FDA Medical Device Classifications
Joint, Elbow, External Limb Component, Powered
IRE · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3420
Classification
- FDA Product Code
IRE- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 890.3420
- Review panel
- PM
- Medical specialty
- Physical Medicine
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 14
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown