510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K062354Substantially Equivalent

Vectra Genisys Vms Fr

Encore Medical, LP, Hixson TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062354 is the FDA 510(k) clearance record for VECTRA GENISYS VMS FR, a class II device, cleared for Encore Medical L.P. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 85 510(k) clearances for Encore Medical L.P., from to . As of , FDA records show no recalls naming K062354.

Clearance record

Decision date
Received
(165 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Encore Medical L.P. 4717 Adams Rd., Hixson TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to November 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260
November 20260