HEEL GARD
FDA 510(k) clearance K790954 · decided 1979-06-20
Clearance details
- K-number
- K790954
- Device name
- HEEL GARD
- Applicant
- Fem-Gard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-05-22
- Decision date
- 1979-06-20
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FRK
- Device class
- 1
- Regulation number
- 880.6140
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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 |
|---|---|---|
| JEDMED J-II CHAIR (K896275) | Jedmed Instrument Co. | 1989-12-18 |
| ULTICARE 2500 TREATMENT CHAIR (K791016) | American Health Care Industries, Inc. | 1979-06-27 |
| COVER GARD (K790955) | Fem-Gard, Inc. | 1979-06-20 |
Recalls involving this device
No recalls on record reference this clearance.