Focus TENS Therapy, Model PM710-M/-L

Q: What is the product code of K183215?

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

FDA 510(k) K183215 · Omron Healthcare, Inc.

Substantially Equivalent

510(k) numberK183215

Submission

Device name: Focus TENS Therapy, Model PM710-M/-L
Applicant: Omron Healthcare, Inc.
Lake Forest, IL, US
Received: November 19, 2018
Decision date: September 7, 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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K252688	Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional	Bozhou Rongjian Medical Appliance Co., Ltd.	11/24/2025SE
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K243131	Triathlon ProNUH · Traditional	Sigma Biomedical	11/07/2025SE

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Questions and answers

When was Focus TENS Therapy, Model PM710-M/-L cleared by the FDA?

Focus TENS Therapy, Model PM710-M/-L (K183215) received a 510(k) decision of Substantially Equivalent on September 7, 2019, 292 days after the submission was received.

What is the product code of K183215?

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