MHW · Dressing, Compression
General Hospital · 21 CFR 880.5075 · Class 1
Overview
| Product Code | MHW |
|---|---|
| Device Name | Dressing, Compression |
| Regulation | 21 CFR 880.5075 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070457 | SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB | Sun Scientific, LLC | May 16, 2007 | SESE |
| K912765 | STASIS BUTTON PRSSURE DEVICE | Arch Development Group | Aug 12, 1991 | SESE |
Top Applicants
- Arch Development Group — 1 clearance
- Sun Scientific, LLC — 1 clearance
