FDA 510(k)

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

Número K: K162517 · 2017-04-14

Data da decisão2017-04-14

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K162517.

When did Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 receive FDA 510(k) clearance?

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

Who is the listed applicant for Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13?

The FDA 510(k) record lists Jkh Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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