FDA 510(k)

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

K-번호: K220578 · 2022-05-25

신청자Bozhou Rongjian Medical Appliance Co., Ltd.

결정일2022-05-25

제품 코드GZJ

자문 위원회NE

결정Substantially Equivalent

기기 요약

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is the device name listed in this FDA 510(k) record. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220578. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Bozhou Rongjian Medical Appliance Co., Ltd.. The 510(k) number is K220578.

When did Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220578.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

The FDA 510(k) record lists Bozhou Rongjian Medical Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) is GZJ.

Bozhou Rongjian Medical Appliance Co., Ltd.를 신청인으로 등재한 기타 기록

K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)K220153Needle Stimulator (Model: RJNS6-1)K213879Self-adhesive Electrode

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