The following data is part of a premarket notification filed by Quantitative Medicine, Inc. with the FDA for Q-tens.
Device ID | K912460 |
510k Number | K912460 |
Device Name: | Q-TENS |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | QUANTITATIVE MEDICINE, INC. 1870 NORTH STATE RD. 7 Matgate, FL 33063 |
Contact | York Mcgavin |
Correspondent | York Mcgavin QUANTITATIVE MEDICINE, INC. 1870 NORTH STATE RD. 7 Matgate, FL 33063 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-04 |
Decision Date | 1991-11-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
Q-TENS 73549602 1408351 Dead/Cancelled |
NDM CORPORATION 1985-07-19 |