SBO — Bed-Patient Activity Monitoring System Class I
FDA product code SBO covers "Bed-Patient Activity Monitoring System", a Class I medical device regulated under 21 CFR 880.2400. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SBO
- Device Class
- Class I
- Regulation Number
- 880.2400
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233096 | position health | PRESSUREALERT® Pressure Monitoring System | June 21, 2024 |