Tai Sheng Various Neox Powered Muscle Stimulator

FDA 510(k) K031310 · Tai Sheng Electrical Machinery Co., Ltd.

Substantially Equivalent

510(k) numberK031310

Submission

Device name
Tai Sheng Various Neox Powered Muscle Stimulator
Applicant
Tai Sheng Electrical Machinery Co., Ltd.
Hsin-Chu City, TW
Received
April 24, 2003
Decision date
April 12, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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Questions and answers

When was Tai Sheng Various Neox Powered Muscle Stimulator cleared by the FDA?

Tai Sheng Various Neox Powered Muscle Stimulator (K031310) received a 510(k) decision of Substantially Equivalent on April 12, 2004, 354 days after the submission was received.

What is the product code of K031310?

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