The following data is part of a premarket notification filed by Empi with the FDA for Empi Model 727,nms.
Device ID | K882631 |
510k Number | K882631 |
Device Name: | EMPI MODEL 727,NMS |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
Contact | George E Mathiesen |
Correspondent | George E Mathiesen EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-27 |
Decision Date | 1988-09-22 |