Cleared Traditional

THERATOUCH 4.7

K932868 · Rich-Mar Corp. · Neurology
Jul 1994
Decision
410d
Days
Class 2
Risk

About This 510(k) Submission

K932868 is an FDA 510(k) clearance for the THERATOUCH 4.7, a Interferential Current Therapy (Class II — Special Controls, product code LIH), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on July 29, 1994, 410 days after receiving the submission on June 14, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K932868 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1993
Decision Date July 29, 1994
Days to Decision 410 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code LIH — Interferential Current Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

Similar Devices — LIH Interferential Current Therapy

All 72
Vecttor VT-300
K231575 · Artaflex, Inc. · Feb 2024
ETD4000
K202725 · Therasigma, LLC · Mar 2021
Avid IF2
K183692 · Vision Quest Industries Inc./Dba VQ Orthocare · Jun 2019
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
K122944 · Gemore Technology Co, Ltd. · Dec 2012
VECTTOR VT-200
K121662 · Alan Neuromedical Technologies, LLC · Nov 2012
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
K110509 · Everyway Medical Instruments Co.,Ltd · Jun 2011