HEEL LOOPS
FDA 510(k) clearance K780193 · decided 1978-02-14
Clearance details
- K-number
- K780193
- Device name
- HEEL LOOPS
- Applicant
- Orthopedic Equipment Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-03
- Decision date
- 1978-02-14
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- KNO
- Device class
- 1
- Regulation number
- 890.3910
- 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 |
|---|---|---|
| REDMAN ACCESSORIES (K870298) | Redman, Inc. | 1987-02-26 |
| FRICTION FEEDER (K823646) | Fred Sammons, Inc. | 1983-01-21 |
| VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR (K823645) | Fred Sammons, Inc. | 1983-01-21 |
| WHEELCHAIR PATIENT RESTRAINTS (K823816) | Danek Medical, Inc. | 1983-01-14 |
| ARM THROUGH FOR WHEELCHAIR BK-6459-01 & (K823636) | Fred Sammons, Inc. | 1982-12-28 |
| CUSHIONS FOR WHEELCHAIR ARMS (K823635) | Fred Sammons, Inc. | 1982-12-28 |
| CLAMP ON HOLDER FOR A GLASS OR CUP (K823596) | Fred Sammons, Inc. | 1982-12-22 |
| HEAD SUPPORT FOR WHEELCHAIR (K823595) | Fred Sammons, Inc. | 1982-12-22 |
| WHEEL CHAIR ACCESSORIES (K821642) | Fred Sammons, Inc. | 1982-06-11 |
| WHEELCHAIR PAL (K820964) | Pryor Products | 1982-04-16 |
| BK-6453 RIMMED ACRYLIC LAP TRAY KIT (K813627) | Fred Sammons, Inc. | 1982-01-19 |
| WHEELCHAIR ACCESSORIES (K812350) | Fred Sammons, Inc. | 1981-09-11 |
Recalls involving this device
No recalls on record reference this clearance.