RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053— 510(k) K071486

Name: FDA 510(k) clearance K071486
Creator: U.S. Food and Drug Administration
Published: 2007-09-10

Substantially Equivalent

Restorative Therapies, Inc.

FDA 510(k) clearance K071486 for RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053, Substantially Equivalent on 2007-09-10. Applicant: Restorative Therapies, Inc.. Device class: 2.

Clearance details

Applicant: Restorative Therapies, Inc.
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2007-05-30
Decision date: 2007-09-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Baltimore, 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 Restorative Therapies, Inc.

view all

K162470 — RT300 FES cycle ergometer2017-07-11
K160614 — Xcite Clinical Station2016-12-16
K103370 — RT2002011-04-05
K103366 — RT6002011-04-04
K090750 — RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA1045812009-08-05

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