FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
TENS STIMULATOR, MODELS 2800 AND 3000
K Number: K102014
·
Decision Aug 31, 2010
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
3
Review Days
46
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Basic Information
- Device Name
- TENS STIMULATOR, MODELS 2800 AND 3000
- K Number
- K102014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Koalaty Products, Inc.
- Date Received
- July 16, 2010
- Decision Date
- August 31, 2010
- 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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