ROCKER-SOLE CAST SANDAL
FDA 510(k) clearance K760575 · decided 1976-10-06
Clearance details
- K-number
- K760575
- Device name
- ROCKER-SOLE CAST SANDAL
- Applicant
- Richard'S Medical Equip., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-09-03
- Decision date
- 1976-10-06
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- IPG
- Device class
- 1
- Regulation number
- 890.3025
- 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 |
|---|---|---|
| NESS CHILDREN SYSTEM (K024279) | Ness-Neuromuscular Electrical Stimulation Systems | 2003-02-05 |
| TOGUARD (K790652) | Togard, Inc. | 1979-04-04 |
| CAST SHOE (K781363) | Cutler Biomedical | 1978-08-14 |
| EQUALIZER (K780617) | Ballert Orthopedic Corp. | 1978-04-18 |
| BALANCED CAST SOLE (K760578) | Parke-Davis Co. | 1976-09-27 |
Recalls involving this device
No recalls on record reference this clearance.