Interx 1000/DERMA 200 Stimulator for Cosmetic Use

FDA 510(k) K070217 · Neuro Resource Group, Inc.

Substantially Equivalent

510(k) numberK070217

Submission

Device name
Interx 1000/DERMA 200 Stimulator for Cosmetic Use
Applicant
Neuro Resource Group, Inc.
Plano, TX, US
Received
January 23, 2007
Decision date
April 4, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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Questions and answers

When was Interx 1000/DERMA 200 Stimulator for Cosmetic Use cleared by the FDA?

Interx 1000/DERMA 200 Stimulator for Cosmetic Use (K070217) received a 510(k) decision of Substantially Equivalent on April 4, 2008, 437 days after the submission was received.

What is the product code of K070217?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.