Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13— 510(k) K162517
Substantially EquivalentJkh Health Co., Ltd.
FDA 510(k) clearance K162517 for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13, Substantially Equivalent on 2017-04-14. Applicant: Jkh Health Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jkh Health Co., Ltd.
- Product code
- Product code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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