THE LEADAWAY
FDA 510(k) clearance K992372 · decided 1999-10-13
Clearance details
- K-number
- K992372
- Device name
- THE LEADAWAY
- Applicant
- Therapy Equipment, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-15
- Decision date
- 1999-10-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- IKD
- Device class
- 2
- Regulation number
- 890.1175
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- West Palm Beach, FL, 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 |
|---|---|---|
| ELECTRODE/EXTENSION CABLES, MODELS ATAR (K070926) | Oscor, Inc. | 2007-06-07 |
| PHYSIOMETRIX CABLE ADAPTER MODIFICATION (K935260) | Physiometrix, Inc. | 1993-12-23 |
| LIFE-SPAN CABLE (K873361) | Chemfet Corp. | 1987-11-09 |
| CLEAR LEADS-RADIOTRANSPARENT WIRES (K834583) | Quinton, Inc. | 1984-01-30 |
| R2 ESU CABLE-ADAPTER MODELS 160,161 (K800934) | R2 Corp. | 1980-05-20 |
Recalls involving this device
No recalls on record reference this clearance.