← FDA Medical Device Classifications
Fall Prevention Alarm/Sensor Attached Only
PJP · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.2400
Classification
- FDA Product Code
PJP- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 880.2400
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt .
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 8
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown