FDA 510(k)

新波電極（モデル：ネックセラピープロ - I、ネックセラピープロ - II、ネックセラピープロ - III、ネックセラピープロ - IV）

K番号: K172887 · 2018-04-19

決定日2018-04-19

製品コードGXY

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) 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 2018-04-19 under 510(k) number K172887. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)?

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K172887.

When did XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) receive FDA 510(k) clearance?

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172887.

Who is the listed applicant for XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)?

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 XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)?

The FDA product code for XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) is GXY.

申請者としてGuangzhou Xinbo Electronic Co., Ltd.を記載するその他の記録

K230711痛み治療装置（モデル：P.T.S-X）K231789痛み治療装置（モデル：P.T.S-VI、P.T.S-VII）K231164導電炭膜電極 K231167導電シリコーンゴム電極 K202671DR-HOの腰痛緩和システムプロ（モデルBPRS-IおよびBPRS-II）K212948痛み治療装置（モデル：DH-P.T.S-I、DH-P.T.S-II、DH-P.T.S-IIA、DH-P.T.S-IIB、DH-CP-I）

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