Bed-Patient Activity Monitoring System
A bed-patient activity monitoring system is a General Hospital device intended to monitor patient activity while lying in bed using pressure sensors placed on multiple body locations or under the mattress, with optional alarms to indicate when patient activity deviates from assigned pressure prevention parameters, helping prevent pressure injuries. It is classified as FDA Class I (general controls) under regulation 880.2400 in the General Hospital specialty, with product code SBO, and does not require 510(k) premarket notification. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SBO
- Device Class
- FDA class 1
- Regulation Number
- 880.2400
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233096 | PRESSUREALERT® Pressure Monitoring System | Jun 21, 2024 | Substantially Equivalent | Position Health, LLC |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.