THERAPY BENCH
FDA 510(k) clearance K812319 · decided 1981-08-31
Clearance details
- K-number
- K812319
- Device name
- THERAPY BENCH
- Applicant
- Kaye Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-08-17
- Decision date
- 1981-08-31
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- IOD
- Device class
- 1
- Regulation number
- 890.5350
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kaye Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DELUXE TRACTION EXERCISE GLOVE BK5035 (K831544) | Fred Sammons, Inc. | 1983-06-24 |
| SURGICAL TUBING (K823648) | Fred Sammons, Inc. | 1983-01-21 |
| ANKLE WEIGHTS (K823822) | Danek Medical, Inc. | 1983-01-14 |
| SOLID WOOD CONE (K823600) | Fred Sammons, Inc. | 1982-12-22 |
| COLOR CODED WEIGHT CUFFS (K813632) | Fred Sammons, Inc. | 1982-01-19 |
| CANVAS WEDGE (K790587) | Maddak, Inc. | 1979-04-03 |
| SANDBAGS, VARIOUS WEIGHTS (K772414) | Fred Sammons, Inc. | 1978-02-01 |
| FLEXION MITTENS (K771030) | Stat Medical Corp. | 1977-06-27 |
| HAND SCREW CLAMP (K761118) | Fred Sammons, Inc. | 1976-12-02 |
| SHEET METAL CLAMP (K761119) | Fred Sammons, Inc. | 1976-12-02 |
Recalls involving this device
No recalls on record reference this clearance.