FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
K Number: K070299
·
Decision Jul 16, 2007
Classifications
1
FEI Numbers
179
Registration Numbers
179
Same Product Code
601
Applicant Total
1
Review Days
166
Basic Information
- Device Name
- EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
- K Number
- K070299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EZFIT TECHNOLOGY INC.
- Date Received
- January 31, 2007
- Decision Date
- July 16, 2007
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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