T-GUARD
FDA 510(k) clearance K945537 · decided 1995-03-23
Clearance details
- K-number
- K945537
- Device name
- T-GUARD
- Applicant
- Med ET AL Development
- Decision
- Substantially Equivalent
- Date received
- 1994-11-14
- Decision date
- 1995-03-23
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- LQX
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Matthews, NC, 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 |
|---|---|---|
| THUMBSHELPER POWER RING (K864870) | Levolon Company, Inc. | 1987-02-12 |
Recalls involving this device
No recalls on record reference this clearance.