TENS & PMS— 510(k) K201354

Name: FDA 510(k) clearance K201354
Creator: U.S. Food and Drug Administration
Published: 2020-12-11

Substantially Equivalent

Hong Qiangxing (Shenzhen) Electronics Limited

FDA 510(k) clearance K201354 for TENS & PMS, Substantially Equivalent on 2020-12-11. Applicant: Hong Qiangxing (Shenzhen) Electronics Limited. Device class: 2.

Clearance details

Applicant: Hong Qiangxing (Shenzhen) Electronics Limited
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2020-05-21
Decision date: 2020-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Hong Qiangxing (Shenzhen) Electronics Limited

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K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D)2025-12-23
K220283 — TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)2022-05-02
K220152 — TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)2022-04-19
K220150 — TENS & PMS (Model: SM9126)2022-02-17
K190009 — Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)2019-12-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.