ANKLE/FOOT EXTERNAL
FDA 510(k) clearance K820505 · decided 1982-03-08
Clearance details
- K-number
- K820505
- Device name
- ANKLE/FOOT EXTERNAL
- Applicant
- Mauch Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-25
- Decision date
- 1982-03-08
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- ISH
- Device class
- 1
- Regulation number
- 890.3420
- 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 |
|---|---|---|
| SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (K051256) | Noble Fiber Technologies, Inc. | 2005-07-21 |
| FREE FLEX HEEL HEIGHT ADJUSTOR (K823396) | Orthopedic Systems, Inc. | 1982-11-29 |
| THE TUCKER-SACH FOOT AND TUCKER-SYME FT (K791331) | Kiswood Manufacturing, Inc. | 1979-08-03 |
Recalls involving this device
No recalls on record reference this clearance.