Muscle Stimulation System 110

FDA 510(k) K150742 · Niveus Medical, Inc.

Substantially Equivalent

510(k) numberK150742

Submission

Device name
Muscle Stimulation System 110
Applicant
Niveus Medical, Inc.
Mountain View, CA, US
Received
March 23, 2015
Decision date
July 23, 2015
Decision
Substantially Equivalent (SESE)
Type
Special 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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Questions and answers

When was Muscle Stimulation System 110 cleared by the FDA?

Muscle Stimulation System 110 (K150742) received a 510(k) decision of Substantially Equivalent on July 23, 2015, 122 days after the submission was received.

What is the product code of K150742?

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