510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K052329Substantially Equivalent

Walkaide System, Models 20-0100, 20-0310, 20-1000

Innovative Neurotronics, Inc., Bethesda MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052329 is the FDA 510(k) clearance record for WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000, a class II device, cleared for Innovative Neurotronics, Inc. on under FDA product code GZI (Stimulator, Neuromuscular, External Functional). FDA records list 3 510(k) clearances for Innovative Neurotronics, Inc., from to . As of , FDA records show one recall naming K052329.

Clearance record

Decision date
Received
(27 days to decision)
Product code
GZI Stimulator, Neuromuscular, External Functional
Regulation
21 CFR 882.5810
Device class
Class II
Review panel
Neurology
Applicant
Innovative Neurotronics, Inc. Two Bethesda Metro Center, Bethesda MD
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