THUMBSHELPER POWER RING
FDA 510(k) clearance K864870 · decided 1987-02-12
Clearance details
- K-number
- K864870
- Device name
- THUMBSHELPER POWER RING
- Applicant
- Levolon Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-12
- Decision date
- 1987-02-12
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- LQX
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Forest Park, GA, 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 |
|---|---|---|
| T-GUARD (K945537) | Med ET AL Development | 1995-03-23 |
Recalls involving this device
No recalls on record reference this clearance.