Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311

FDA 510(k) K071320 · Everlife Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK071320

Submission

Device name
Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311
Applicant
Everlife Medical Equipment Co., Ltd.
Hsin-Chu City, TW
Received
May 10, 2007
Decision date
August 17, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IPF – Stimulator, Muscle, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5850
Specialty
Physical Medicine

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More from Sunmed, LLC

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Questions and answers

When was Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 cleared by the FDA?

Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 (K071320) received a 510(k) decision of Substantially Equivalent on August 17, 2007, 99 days after the submission was received.

What is the product code of K071320?

The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.