Sun-Tens Palm Type R5/COMPACT Wireles M2 EMS Series

FDA 510(k) K011913 · Sun-Rain System Corp.

Substantially Equivalent

510(k) numberK011913

Submission

Device name
Sun-Tens Palm Type R5/COMPACT Wireles M2 EMS Series
Applicant
Sun-Rain System Corp.
Hsin-Chu City, TW
Received
June 19, 2001
Decision date
October 26, 2001
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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More from Sunmed, LLC

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Questions and answers

When was Sun-Tens Palm Type R5/COMPACT Wireles M2 EMS Series cleared by the FDA?

Sun-Tens Palm Type R5/COMPACT Wireles M2 EMS Series (K011913) received a 510(k) decision of Substantially Equivalent on October 26, 2001, 129 days after the submission was received.

What is the product code of K011913?

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