Definition: A Pressure Ulcer Management Tool Is A Prescription Device Intended For Patients At Risk Of Developing Pressure Ulcers. The Device Provides Output That Supports A User’s Decision To Increase Intervention. The Device Is An Adjunct Tool For Pressure Ulc
| Device Type ID | 2161 |
| Device Name | Pressure Ulcer Management Tool |
| Physical State | A Cordless, Hand-held Portable Device. |
| Technical Method | Intended To Be Placed On Intact Skin Of A Patient's Sacrum Or Heels To Measure The Electrical Capacitance Via A Coaxial Electrode. |
| Target Area | Sacrum Or Heels. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.2100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | QEF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2161 |
| Device | Pressure Ulcer Management Tool |
| Product Code | QEF |
| FDA Device Classification | Class 1 Medical Device |
| CFR Regulation Number | 876.2100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRUIN BIOMETRICS, LLC | ||
GRANTED | 1 | |