K233096 is an FDA 510(k) clearance for the PRESSUREALERT® Pressure Monitoring System. This device is classified as a Bed-patient Activity Monitoring System (Class I - General Controls, product code SBO).
Submitted by Position Health, LLC (Lake Forest, US). The FDA issued a Cleared decision on June 21, 2024, 269 days after receiving the submission on September 26, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2400. 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) Number | K233096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2023 |
| Decision Date | June 21, 2024 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | SBO - Bed-patient Activity Monitoring System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.2400 |
| 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. |