Electropulse-Cosmetic

FDA 510(k) K113724 · Pain Relief Technologies

Substantially Equivalent

510(k) numberK113724

Submission

Device name
Electropulse-Cosmetic
Applicant
Pain Relief Technologies
Beaverton, OR, US
Received
December 19, 2011
Decision date
February 15, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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More from Shenzhen Qianyu Technology Co., Ltd.

510(k)DeviceDecision
K062532Electropulse - Low Back PainNUH · Traditional 02/09/2007SE
K051128ElectropulseGZJ · Traditional 03/10/2006SE

Questions and answers

When was Electropulse-Cosmetic cleared by the FDA?

Electropulse-Cosmetic (K113724) received a 510(k) decision of Substantially Equivalent on February 15, 2012, 58 days after the submission was received.

What is the product code of K113724?

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