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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 the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2019-09-07 under 510(k) 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. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K183215.

When did Focus TENS Therapy, Model PM710-M/-L receive FDA 510(k) clearance?

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

Who is the listed applicant for Focus TENS Therapy, Model PM710-M/-L?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Omron Healthcare, Inc. as applicant

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Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

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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