ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)— 510(k) K152852
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K152852 for ALEVE Direct Therapy (ALEVE Direct Therapy TENS device), Substantially Equivalent on 2015-12-22. 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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More clearances from Bayer Healthcare, LLC
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- K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER
- K121190 — CONTOUR NEXT BLOOD GLUCOSE METER
- K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
- K093930 — DIDGET WORLD REPORTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.