ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)— 510(k) K171802
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K171802 for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device), Substantially Equivalent on 2018-03-07. Applicant: Bayer Healthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Whippany, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.