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FDA 510(k)

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

K-Number: K171802 · 2018-03-07

ApplicantBayer Healthcare, LLC
Decision Date2018-03-07
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is a medical device manufactured by Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2018-03-07 under approval number K171802. 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 ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is a medical device that received FDA 510(k) clearance on 2018-03-07. It is manufactured by Bayer Healthcare, LLC. The 510(k) number is K171802.

When was ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) approved by the FDA?

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) received FDA 510(k) clearance on 2018-03-07, under approval number K171802.

What company makes ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is manufactured by Bayer Healthcare, LLC.

What is the FDA product code for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

The FDA product code for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is NUH.

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Related PubMed Literature

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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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