C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES › Subpart F—General Hospital and Personal Use Therapeutic Devices

21 C.F.R. § 880.5075

Elastic bandage

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(a) Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

(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 § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001; 90 FR 55986, Dec. 4, 2025]
Notes of Decisions
Cited in 3 cases, 1998–2011 · leading case: Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128 (D. Minnesota 2011).
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Kapps v. Biosense Webster, Inc., 813 F. Supp. 2d 1128 (D. Minnesota 2011). “1220 (electrode recording catheter or electrode recording probe), 870.3925 (replacement heart valve), 870.”
Sita v. Danek Med., Inc., 43 F. Supp. 2d 245 (E.D.N.Y 1999). “§ 360c(a)(1)(A); 21 C.F.R. §§ 880.5075 , 880.6280, 880.6730, 890.”
Baker v. Danek Med., 35 F. Supp. 2d 865 (N.D. Fla. 1998). “21 C.F.R. §§ 880.5075 , 880.6230, 886.5850, 890.”
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