← FDA Medical Device Classifications
Infant Heel Warmer (Chemical Heat Pack)
MPO · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.5710
Classification
- FDA Product Code
MPO- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 890.5710
- Review panel
- PM
- Medical specialty
- Physical Medicine
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 11
- Registered establishments
- 23
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown