ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K-Number: K171802 · 2018-03-07
Device Summary
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. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K171802.
When did ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) receive FDA 510(k) clearance?
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) received FDA 510(k) clearance on 2018-03-07, under 510(k) number K171802.
Who is the listed applicant for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?
The FDA 510(k) record lists Bayer Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.
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.
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.
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.