SBO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Bed-Patient Activity Monitoring System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2400
- Medical specialty
- General Hospital
- FDA definition
- A bed-patient activity monitoring system is intended to monitor activity of patients while lying in a bed using pressure sensors placed on multiple parts of the body or locations under the mattress. The system may indicate by an alarm or other signal when patient activity deviates from assigned pressure prevention parameters.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PRESSUREALERT® Pressure Monitoring System (K233096) | Position Health, LLC | 2024-06-21 |
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Every clearance here is in the API, with alerts when new ones post.