Tips And Pads, Cane, Crutch And Walker
Tips and Pads for Canes, Crutches, and Walkers are replacement or accessory components attached to the bottom of walking aids to improve grip and traction on surfaces, reduce shock transmission, and protect floors, used in Physical Medicine to enhance safety and comfort for ambulatory patients with mobility impairments. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is INP, regulated under 21 CFR 890.3790, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- INP
- Device Class
- FDA class 1
- Regulation Number
- 890.3790
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831889 | SURGEON'S CHOICE CRUTCH HANDLE | Jul 07, 1983 | Substantially Equivalent | W.K. Wheeler, Inc. |
| K831149 | PERSONAL KNEE CRUTCH PAD | May 03, 1983 | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. |
| K811493 | CRUTCH & WALKER PADS | Jun 12, 1981 | Substantially Equivalent | Fred Sammons, Inc. |
| K810650 | CRUTCH TIPS & GRIPS | Mar 26, 1981 | Substantially Equivalent | First Industries, Inc. |
| K803144 | CONPHAR CRUTCH PADS | Jan 08, 1981 | Substantially Equivalent | Conphar, Inc. |
| K803140 | CONPHAR CRUTCH GRIPS | Jan 08, 1981 | Substantially Equivalent | Conphar, Inc. |
| K803136 | CONPHAR CRUTCH TIPS | Jan 08, 1981 | Substantially Equivalent | Conphar, Inc. |
| K800076 | CRUTCH TIPS, PADS & HAND GRIPS | Jan 28, 1980 | Substantially Equivalent | New World Imports, Inc. |
FEI Numbers
This FDA classification entry is associated with 144 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 144 registration numbers. Click on an entry to view related FDA registrations.