510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K050991Substantially Equivalent

The Odfs Dropped Foot Stimulator

Department of Medical Physics and Biomedical Eng., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050991 is the FDA 510(k) clearance record for THE ODFS DROPPED FOOT STIMULATOR, a class II device, cleared for Department of Medical Physics and Biomedical Eng. on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list one 510(k) clearance for Department of Medical Physics and Biomedical Eng. As of , FDA records show no recalls naming K050991.

Clearance record

Decision date
Received
(87 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Department of Medical Physics and Biomedical Eng. One Chagrin Highlands 2000, Cleveland OH
510(k) summary
Summary PDF
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