Electrosurgical disposable grounding pads— 510(k) K160366

Name: FDA 510(k) clearance K160366
Creator: U.S. Food and Drug Administration
Published: 2016-08-19

Substantially Equivalent

Top-Rank Health Care Co., Ltd.

FDA 510(k) clearance K160366 for Electrosurgical disposable grounding pads, Substantially Equivalent on 2016-08-19. Applicant: Top-Rank Health Care Co., Ltd.. Device class: 2.

Clearance details

Applicant: Top-Rank Health Care Co., Ltd.
Product code: Code ODR
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2016-02-09
Decision date: 2016-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shaoxing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODR

view all

K121268 — WANDY DISPERSVIE ELECTRODE2012-12-20
K082204 — SERIES SY DISPOSABLE ELECTROSURGICAL PAD2008-08-13

More clearances from Top-Rank Health Care Co., Ltd.

view all

K232020 — Iontophoresis Electrodes2023-10-16
K222770 — Conductive Gel2022-12-13
K210223 — Transcutaneous Electrical Nerve Stimulator2021-12-15

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