FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ThermaCare Quick Therapy TENS
K Number: K181102
·
Decision Sep 15, 2018
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
30
Review Days
142
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Basic Information
- Device Name
- ThermaCare Quick Therapy TENS
- K Number
- K181102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pfizer, Inc.
- Date Received
- April 26, 2018
- Decision Date
- September 15, 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
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| K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | Feb 24, 1986 | Substantially Equivalent |
| K850413 | MEC HIP BOLT | Jul 15, 1985 | Substantially Equivalent |
| K850403 | MEC DISTAL FEMORAL BOLT | Jul 15, 1985 | Substantially Equivalent |
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| K850443 | MEC ROD CONNECTOR | Jul 15, 1985 | Substantially Equivalent |
| K851971 | SERIES 7000/HOLTER RECORDER | Jun 20, 1985 | Substantially Equivalent |