The following data is part of a premarket notification filed by Therapy Equipment, Inc. with the FDA for The Leadaway.
| Device ID | K992372 |
| 510k Number | K992372 |
| Device Name: | THE LEADAWAY |
| Classification | Cable, Electrode |
| Applicant | THERAPY EQUIPMENT, INC. 13860 WELLINGTON TRACE, #310 West Palm Beach, FL 33414 |
| Contact | Glenn Buchan |
| Correspondent | Glenn Buchan THERAPY EQUIPMENT, INC. 13860 WELLINGTON TRACE, #310 West Palm Beach, FL 33414 |
| Product Code | IKD |
| CFR Regulation Number | 890.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-15 |
| Decision Date | 1999-10-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THE LEADAWAY 75701917 2483216 Dead/Cancelled |
Therapy Equipment, Inc. 1999-05-10 |