The following data is part of a premarket notification filed by Empi with the FDA for Focus Model 795 Unit.
Device ID | K951951 |
510k Number | K951951 |
Device Name: | FOCUS MODEL 795 UNIT |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
Contact | Stacey Mattson |
Correspondent | Stacey Mattson EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
Product Code | GZJ |
Subsequent Product Code | GZI |
Subsequent Product Code | IPF |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-26 |
Decision Date | 1996-05-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B36711001L00 | K951951 | 000 |