The following data is part of a premarket notification filed by Empi with the FDA for Empi Model 720 Nms, Tens.
Device ID | K861451 |
510k Number | K861451 |
Device Name: | EMPI MODEL 720 NMS, TENS |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
Contact | George Mathiesen |
Correspondent | George Mathiesen EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-18 |
Decision Date | 1986-07-03 |