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FDA 510(k)

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13

K-Number: K162517 · 2017-04-14

ApplicantJkh Health Co., Ltd.
Decision Date2017-04-14
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is a medical device manufactured by Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2017-04-14 under approval number K162517. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is a medical device that received FDA 510(k) clearance on 2017-04-14. It is manufactured by Jkh Health Co., Ltd.. The 510(k) number is K162517.

When was Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 approved by the FDA?

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 received FDA 510(k) clearance on 2017-04-14, under approval number K162517.

What company makes Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is manufactured by Jkh Health Co., Ltd..

What is the FDA product code for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

The FDA product code for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 is NUH.

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Other Devices by Jkh Health Co., Ltd.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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