IPR · Crutch
Physical Medicine · 21 CFR 890.3150 · Class 1
Overview
| Product Code | IPR |
|---|---|
| Device Name | Crutch |
| Regulation | 21 CFR 890.3150 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.
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 § 890.9. The device 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K821403 | LIGHT WEIGHT ALUMINUM CRUTCHES | Manuco Manufacturing Co., Inc. | Jun 21, 1982 | SESE |
| K800237 | FOLDING CRUTCH | Husa Folding Crutch Co., Inc. | Feb 22, 1980 | SESE |
| K790557 | CRUTCH | Maddak, Inc. | Apr 3, 1979 | SESE |
| K770146 | SWIVEL HEAD ADJUSTABLE CRUTCH | Maddak, Inc. | Jan 28, 1977 | SESE |
Top Applicants
- Maddak, Inc. — 2 clearances
- Husa Folding Crutch Co., Inc. — 1 clearance
- Manuco Manufacturing Co., Inc. — 1 clearance
