21 CFR 880.5075 — Bandage, Elastic
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5075
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FQM | Bandage, Elastic | 1 | 42 | |
| MCY | Wound Dressing Kit | 2 | 24 | |
| MHW | Dressing, Compression | 1 | 2 | |
| OXQ | Dressing Change Tray | 1 | 0 |
