FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
K Number: K162517
·
Decision Apr 14, 2017
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
216
Applicant Total
5
Review Days
217
Basic Information
- Device Name
- Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
- K Number
- K162517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JKH Health Co., Ltd.
- Date Received
- September 9, 2016
- Decision Date
- April 14, 2017
- 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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