510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800380Substantially Equivalent

Fes Orthosis Model No. 2000

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

K800380 is the FDA 510(k) clearance record for FES ORTHOSIS MODEL NO. 2000, a class II device, cleared for Empi on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list 5 510(k) clearances for Empi, from to . As of , FDA records show no recalls naming K800380.

Clearance record

Decision date
Received
(24 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Empi 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