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- Subpart B—Diagnostic DevicesCFR Sub-Part
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- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
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- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
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Pressure Ulcer Management Tool
- Page Type
- Product Code
- 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 ulcer management that is not intended for detection or diagnostic purposes.
- 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 and Urology
- Review Panel
- Gastroenterology and Urology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 876.2100
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 876.2100 Pressure ulcer management tool
§ 876.2100 Pressure ulcer management tool.
(a) Identification. 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 ulcer management that is not intended for detection or diagnostic purposes.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 876.9.
[86 FR 70735, Dec. 13, 2021]