FSD · Binder, Abdominal
General Hospital · 21 CFR 880.5160 · Class 1
Overview
| Product Code | FSD |
|---|---|
| Device Name | Binder, Abdominal |
| Regulation | 21 CFR 880.5160 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.
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. If the device is not labeled or otherwise represented as sterile, it is also 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K892379 | THE POUCH GROIN & ABDOMINAL STRESS AID | Kuhn Industries | Jul 20, 1989 | SESE |
| K822817 | DOCE ALL-IN-THE-EAR AID | Fidelty Hearing Instruments, Inc. | Jan 18, 1983 | SESE |
| K810379 | EARETTE HEARING AID SEARS #8054 | Oticon Corp. | Mar 4, 1981 | SESE |
| K770162 | MATERNITY SUPPORTER | R.G. Moore | Feb 9, 1977 | SESE |
| K760772 | DISPOSABLE ABDOMINAL BINDER | Tecnol New Jersey Wound Care, Inc. | Nov 3, 1976 | SESE |
Top Applicants
- Fidelty Hearing Instruments, Inc. — 1 clearance
- Kuhn Industries — 1 clearance
- Oticon Corp. — 1 clearance
- R.G. Moore — 1 clearance
- Tecnol New Jersey Wound Care, Inc. — 1 clearance
