The following data is part of a premarket notification filed by Empi with the FDA for Empi Model 730 Nms.
Device ID | K854775 |
510k Number | K854775 |
Device Name: | EMPI MODEL 730 NMS |
Classification | Stimulator, Muscle, Powered |
Applicant | EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
Contact | George E Mathiesen |
Correspondent | George E Mathiesen EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-29 |
Decision Date | 1986-02-12 |