Cleared Traditional

RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE

K952089 · Rich-Mar Corp. · Neurology
Aug 1995
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K952089 is an FDA 510(k) clearance for the RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE, 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 August 11, 1995, 100 days after receiving the submission on May 3, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K952089 FDA.gov
FDA Decision Cleared SN
Date Received May 03, 1995
Decision Date August 11, 1995
Days to Decision 100 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

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

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