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FDA 510(k)

Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

K-Number: K181207 · 2018-06-06

ApplicantEveryway Medical Instruments Co., Ldt.
Decision Date2018-06-06
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is a medical device manufactured by Everyway Medical Instruments Co., Ldt.. It received FDA 510(k) clearance on 2018-06-06 under approval number K181207. 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 Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is a medical device that received FDA 510(k) clearance on 2018-06-06. It is manufactured by Everyway Medical Instruments Co., Ldt.. The 510(k) number is K181207.

When was Balego TENS Digital Edition with Accessories for Pain Relief (OTC) approved by the FDA?

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) received FDA 510(k) clearance on 2018-06-06, under approval number K181207.

What company makes Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is manufactured by Everyway Medical Instruments Co., Ldt..

What is the FDA product code for Balego TENS Digital Edition with Accessories for Pain Relief (OTC)?

The FDA product code for Balego TENS Digital Edition with Accessories for Pain Relief (OTC) is NUH.

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Other Devices by Everyway Medical Instruments Co., Ldt.

K181849iStim S2 OTC Pain Relief TENS

Related Devices (Code: 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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