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FDA 510(k)

Pain Therapy Device

K-Number: K202638 · 2021-07-15

ApplicantGuangzhou Xinbo Electronic Co., Ltd.
Decision Date2021-07-15
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Pain Therapy Device is a medical device manufactured by Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2021-07-15 under approval number K202638. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pain Therapy Device?

Pain Therapy Device is a medical device that received FDA 510(k) clearance on 2021-07-15. It is manufactured by Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K202638.

When was Pain Therapy Device approved by the FDA?

Pain Therapy Device received FDA 510(k) clearance on 2021-07-15, under approval number K202638.

What company makes Pain Therapy Device?

Pain Therapy Device is manufactured by Guangzhou Xinbo Electronic Co., Ltd..

What is the FDA product code for Pain Therapy Device?

The FDA product code for Pain Therapy Device is NGX.

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Related PubMed Literature

PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

Other Devices by Guangzhou Xinbo Electronic Co., Ltd.

K163611Pain Therapy Device K172887XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) K200402DR-HO'S Electro Therapy Conductive Gel K190118Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) K202671DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) K212948Pain 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)

View all 12 devices →

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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.

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