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Code · CFR · Title 21 — Food and Drugs · Part 876 — Gastroenterology-Urology Devices · § 876.2100

§ 876.2100. Pressure ulcer management tool.

88 words·~1 min read·/us/cfr/t21/s§ 876.2100·

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(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]
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§ 876.2100
Pressure ulcer management tool.
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