SBOClass I
Bed-Patient Activity Monitoring System
21 CFR 880.2400 / General Hospital
SBO is the FDA product code for Bed-Patient Activity Monitoring System, a class I device type, regulated under 21 CFR 880.2400. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SBO
- Device name
- Bed-Patient Activity Monitoring System
- 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.
- Regulation
- 21 CFR 880.2400
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SBO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code SBO| Applicant | Clearances |
|---|---|
| Position Health, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.