WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000— 510(k) K052329

Name: FDA 510(k) clearance K052329
Creator: U.S. Food and Drug Administration
Published: 2005-09-21

Substantially Equivalent

Innovative Neurotronics, Inc.

FDA 510(k) clearance K052329 for WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000, Substantially Equivalent on 2005-09-21. Applicant: Innovative Neurotronics, Inc.. Device class: 2.

Clearance details

Applicant: Innovative Neurotronics, Inc.
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2005-08-25
Decision date: 2005-09-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZI

view all

K242704 — Synchrony (20-3000)2025-06-05
K243828 — CIONIC NEURAL SLEEVE (NS-200)2025-05-02
K240632 — Neuvotion NeuStim NN-012024-11-22
K233006 — MyndMove, MyndMove 2.02024-06-25
K230997 — EvoWalk 1.0 System2023-12-28

More clearances from Innovative Neurotronics, Inc.

view all

K140886 — WALKAIDE SYSTEM2014-08-08
K123972 — WALKAIDE SYSTEM2013-04-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.