Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K202671 · 2021-11-12

ApplicantGuangzhou Xinbo Electronic Co., Ltd.
Decision Date2021-11-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Guangzhou Xinbo Electronic Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230711Pain Therapy Device(Model: P.T.S-X)K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)K231167Conductive Silicone Rubber ElectrodeK231164Conductive carbon film electrodeK212948Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)K202636Metallic Fabric Electrodes

View all 12 devices →

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

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.

↑