FDA 510(k)

iStim S2 OTC 통증 완화 TENS

K-번호: K181849 · 2018-08-10

신청자Everyway Medical Instruments Co., Ldt.

결정일2018-08-10

제품 코드NUH

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

iStim S2 OTC Pain Relief TENS is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co., Ldt.. It received FDA 510(k) clearance on 2018-08-10 under 510(k) number K181849. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the iStim S2 OTC Pain Relief TENS?

iStim S2 OTC Pain Relief TENS is a medical device that received FDA 510(k) clearance on 2018-08-10. The listed applicant is Everyway Medical Instruments Co., Ldt.. The 510(k) number is K181849.

When did iStim S2 OTC Pain Relief TENS receive FDA 510(k) clearance?

iStim S2 OTC Pain Relief TENS received FDA 510(k) clearance on 2018-08-10, under 510(k) number K181849.

Who is the listed applicant for iStim S2 OTC Pain Relief TENS?

The FDA 510(k) record lists Everyway Medical Instruments Co., Ldt. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iStim S2 OTC Pain Relief TENS?

The FDA product code for iStim S2 OTC Pain Relief TENS is NUH.

Everyway Medical Instruments Co., Ldt.를 신청인으로 등재한 기타 기록

K181207Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

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