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 |