{"data":{"id":"us/21-cfr-876.2100","jurisdiction":"us","citation":"21 CFR 876.2100","heading":"Pressure ulcer management tool.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 876—GASTROENTEROLOGY-UROLOGY DEVICES","Subpart C—Monitoring Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"770f6c6872a76305c20b8de07dcfae3b35e8649492bf2a25e52fb0e8ba44c48d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.2050","next":"us/21-cfr-876.3350"},"notice":"GroundRules: Original legal text. Not legal advice."}