BARS, PARALLEL, EXERCISE
FDA 510(k) clearance K830466 · decided 1983-03-09
Clearance details
- K-number
- K830466
- Device name
- BARS, PARALLEL, EXERCISE
- Applicant
- Kaye Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-15
- Decision date
- 1983-03-09
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- IOE
- Device class
- 1
- Regulation number
- 890.5370
- 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 |
|---|---|---|
| PARALLEL BARS (K770611) | Will Ross Co. | 1977-04-08 |
Recalls involving this device
No recalls on record reference this clearance.