Cleared Traditional

K060222 - LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
(FDA 510(k) Clearance)

K060222 · Gemore Technology Co, Ltd. · Neurology

Apr 2006

Decision

88d

Days

Class 2

Risk

K060222 is an FDA 510(k) clearance for the LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH).

Submitted by Gemore Technology Co, Ltd. (Tan Shui, New Taipei City, TW). The FDA issued a Cleared decision on April 28, 2006, 88 days after receiving the submission on January 30, 2006.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890. Temporary Relief Of Pain Due To Sore/aching Muscles.

Submission Details

510(k) Number	K060222 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2006
Decision Date	April 28, 2006
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles