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FDA 510(k)

Focus TENS Therapy, Model PM710-M/-L

K-Number: K183215 · 2019-09-07

ApplicantOmron Healthcare, Inc.
Decision Date2019-09-07
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Focus TENS Therapy, Model PM710-M/-L is a medical device manufactured by Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2019-09-07 under approval number K183215. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Focus TENS Therapy, Model PM710-M/-L?

Focus TENS Therapy, Model PM710-M/-L is a medical device that received FDA 510(k) clearance on 2019-09-07. It is manufactured by Omron Healthcare, Inc.. The 510(k) number is K183215.

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

Focus TENS Therapy, Model PM710-M/-L received FDA 510(k) clearance on 2019-09-07, under approval number K183215.

What company makes Focus TENS Therapy, Model PM710-M/-L?

Focus TENS Therapy, Model PM710-M/-L is manufactured by Omron Healthcare, Inc..

What is the FDA product code for Focus TENS Therapy, Model PM710-M/-L?

The FDA product code for Focus TENS Therapy, Model PM710-M/-L is NUH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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