The following data is part of a premarket notification filed by Empi with the FDA for Epix Vt.
Device ID | K970203 |
510k Number | K970203 |
Device Name: | EPIX VT |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
Contact | Stacy Mattson |
Correspondent | Stacy Mattson EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-21 |
Decision Date | 1997-04-14 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EPIX VT 75225364 2169128 Dead/Cancelled |
EMPI CORP 1997-01-14 |