510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813515Substantially Equivalent

Veri/dfs Tm #817

Verite, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813515 is the FDA 510(k) clearance record for VERI/DFS TM #817, a class II device, cleared for Verite on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list 10 510(k) clearances for Verite, from to . As of , FDA records show no recalls naming K813515.

Clearance record

Decision date
Received
(35 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Verite 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GZI

Trailing 12 months

FDA records hold no clearances under product code GZI in the trailing twelve months.

FDA records show no clearances under product code GZI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260