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 | ||
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Manufacturer | Decision | |
BRUIN BIOMETRICS, LLC | ||
GRANTED | 1 |