FDA 510(k)

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)

Numéro K : K202671 · 2021-11-12

DemandeurGuangzhou Xinbo Electronic Co., Ltd.

Date de décision2021-11-12

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K202671. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)?

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K202671.

When did DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) receive FDA 510(k) clearance?

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) received FDA 510(k) clearance on 2021-11-12, under 510(k) number K202671.

Who is the listed applicant for DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)?

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

What is the FDA product code for DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)?

The FDA product code for DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) is NUH.

Essais cliniques associés

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Source officielle

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