SURGEON'S CHOICE CRUTCH HANDLE
FDA 510(k) clearance K831889 · decided 1983-07-07
Clearance details
- K-number
- K831889
- Device name
- SURGEON'S CHOICE CRUTCH HANDLE
- Applicant
- W.K. Wheeler, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-14
- Decision date
- 1983-07-07
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- INP
- Device class
- 1
- Regulation number
- 890.3790
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PERSONAL KNEE CRUTCH PAD (K831149) | Tecnol New Jersey Wound Care, Inc. | 1983-05-03 |
| CRUTCH & WALKER PADS (K811493) | Fred Sammons, Inc. | 1981-06-12 |
| CRUTCH TIPS & GRIPS (K810650) | First Industries, Inc. | 1981-03-26 |
| CONPHAR CRUTCH TIPS (K803136) | Conphar, Inc. | 1981-01-08 |
| CONPHAR CRUTCH GRIPS (K803140) | Conphar, Inc. | 1981-01-08 |
| CONPHAR CRUTCH PADS (K803144) | Conphar, Inc. | 1981-01-08 |
| CRUTCH TIPS, PADS & HAND GRIPS (K800076) | New World Imports, Inc. | 1980-01-28 |
Recalls involving this device
No recalls on record reference this clearance.