FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K Number: K171802
·
Decision Mar 7, 2018
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
46
Review Days
261
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Basic Information
- Device Name
- ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
- K Number
- K171802
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Healthcare, LLC
- Date Received
- June 19, 2017
- Decision Date
- March 7, 2018
- Product Code
- NUH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUH), ordered by most recent decision date.
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
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TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
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TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
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VEINOPLUS Back
FDA 510(k)
FDA Class 2
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Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Bayer Healthcare, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | Dec 22, 2015 | Substantially Equivalent |
| K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER | Jun 23, 2014 | Substantially Equivalent |
| K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | Jul 26, 2012 | Substantially Equivalent |
| K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) | Mar 28, 2012 | Substantially Equivalent |
| K093930 | DIDGET WORLD REPORTS | Mar 12, 2010 | Substantially Equivalent |
| K090628 | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 | Dec 4, 2009 | Substantially Equivalent |
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC | May 14, 2009 | Substantially Equivalent |
| K082486 | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE | Oct 8, 2008 | Substantially Equivalent |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | Dec 7, 2007 | Substantially Equivalent |
| K063276 | CLINITEK ADVANTUS, MODEL 1420 | Dec 28, 2006 | Substantially Equivalent |