Crutch
A Crutch is an ambulatory assistive device used in Physical Medicine to partially offload weight from an injured or weakened lower limb, enabling patients with leg injuries, fractures, or post-surgical conditions to walk with partial or full non-weight-bearing gait. Available in axillary and forearm (Lofstrand) styles, crutches are among the most commonly used mobility aids in rehabilitation. 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 IPR, regulated under 21 CFR 890.3150, 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
- IPR
- Device Class
- FDA class 1
- Regulation Number
- 890.3150
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K821403 | LIGHT WEIGHT ALUMINUM CRUTCHES | Jun 21, 1982 | Substantially Equivalent | Manuco Manufacturing Co., Inc. |
| K800237 | FOLDING CRUTCH | Feb 22, 1980 | Substantially Equivalent | Husa Folding Crutch Co., Inc. |
| K790557 | CRUTCH | Apr 03, 1979 | Substantially Equivalent | Maddak, Inc. |
| K770146 | SWIVEL HEAD ADJUSTABLE CRUTCH | Jan 28, 1977 | Substantially Equivalent | Maddak, Inc. |
FEI Numbers
This FDA classification entry is associated with 196 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 196 registration numbers. Click on an entry to view related FDA registrations.