FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRONIC PULSE STIMULATOR
K Number: K141260
·
Decision Sep 17, 2014
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
3
Review Days
125
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Basic Information
- Device Name
- ELECTRONIC PULSE STIMULATOR
- K Number
- K141260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Jingkehui Electronic Co.., Ltd.
- Date Received
- May 15, 2014
- Decision Date
- September 17, 2014
- 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 |
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