INP · Tips And Pads, Cane, Crutch And Walker
Physical Medicine · 21 CFR 890.3790 · Class 1
Overview
| Product Code | INP |
|---|---|
| Device Name | Tips And Pads, Cane, Crutch And Walker |
| Regulation | 21 CFR 890.3790 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
Cane, crutch, and walker tips and pads are rubber (or rubber substitute) device accessories intended for medical purposes that are applied to the ground end of mobility aids to prevent skidding or that are applied to the body contact area of the device for comfort or as an aid in using an ambulatory assist device.
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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831889 | SURGEON'S CHOICE CRUTCH HANDLE | W.K. Wheeler, Inc. | Jul 7, 1983 | SESE |
| K831149 | PERSONAL KNEE CRUTCH PAD | Tecnol New Jersey Wound Care, Inc. | May 3, 1983 | SESE |
| K811493 | CRUTCH & WALKER PADS | Fred Sammons, Inc. | Jun 12, 1981 | SESE |
| K810650 | CRUTCH TIPS & GRIPS | First Industries, Inc. | Mar 26, 1981 | SESE |
| K803144 | CONPHAR CRUTCH PADS | Conphar, Inc. | Jan 8, 1981 | SESE |
| K803140 | CONPHAR CRUTCH GRIPS | Conphar, Inc. | Jan 8, 1981 | SESE |
| K803136 | CONPHAR CRUTCH TIPS | Conphar, Inc. | Jan 8, 1981 | SESE |
| K800076 | CRUTCH TIPS, PADS & HAND GRIPS | New World Imports, Inc. | Jan 28, 1980 | SESE |
Top Applicants
- Conphar, Inc. — 3 clearances
- First Industries, Inc. — 1 clearance
- Fred Sammons, Inc. — 1 clearance
- New World Imports, Inc. — 1 clearance
- Tecnol New Jersey Wound Care, Inc. — 1 clearance
