The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Vectra Genisys Vms Fr.
Device ID | K062354 |
510k Number | K062354 |
Device Name: | VECTRA GENISYS VMS FR |
Classification | Stimulator, Muscle, Powered |
Applicant | ENCORE MEDICAL, L.P. 4717 ADAMS ROAD Hixson, TN 37343 |
Contact | Michael Treas |
Correspondent | Michael Treas ENCORE MEDICAL, L.P. 4717 ADAMS ROAD Hixson, TN 37343 |
Product Code | IPF |
Subsequent Product Code | GZI |
Subsequent Product Code | GZJ |
Subsequent Product Code | HCC |
Subsequent Product Code | IMG |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-14 |
Decision Date | 2007-01-26 |
Summary: | summary |