Maxpower Relief

FDA 510(k) K182120 · Omron Healthcare, Inc.

Substantially Equivalent

510(k) numberK182120

Submission

Device name
Maxpower Relief
Applicant
Omron Healthcare, Inc.
Lake Forest, IL, US
Received
August 6, 2018
Decision date
January 10, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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Questions and answers

When was Maxpower Relief cleared by the FDA?

Maxpower Relief (K182120) received a 510(k) decision of Substantially Equivalent on January 10, 2019, 157 days after the submission was received.

What is the product code of K182120?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.