Adhesive Electrodes

Electrode, Cutaneous

GMDASZ MANUFACTURING CO., LTD

The following data is part of a premarket notification filed by Gmdasz Manufacturing Co., Ltd with the FDA for Adhesive Electrodes.

Pre-market Notification Details

• Device ID: K160138
• 510k Number: K160138
• Device Name: Adhesive Electrodes
• Classification: Electrode, Cutaneous
• Applicant: GMDASZ MANUFACTURING CO., LTD ROOM E1308, XIHAIMINGZHU BUILDING, TAOYUAN ROAD NANSHAN DISTRICT Shenzhen City, CN 518052
• Contact: Charles Mack
• Correspondent: Charles Mack; IRC 2250 DUPORTAIL STREET, M275 Richland, WA 99352
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-01-21
• Decision Date: 2016-08-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04260280180533	K160138	000
06970341677367	K160138	000
06970341677411	K160138	000
06970341677343	K160138	000
06970341677312	K160138	000
00697034167740	K160138	000
06970341677299	K160138	000
06970341677282	K160138	000
06970341677275	K160138	000
06970341677381	K160138	000
06970341677398	K160138	000
06970341677503	K160138	000
06970341677480	K160138	000
06970341677473	K160138	000
06970341677466	K160138	000
06970341677459	K160138	000
06970341677442	K160138	000
06970341677435	K160138	000
06970341677428	K160138	000
06970341670245	K160138	000
06970341677251	K160138	000
04260280181349	K160138	000
04260280180960	K160138	000
04260280180830	K160138	000
04260280180793	K160138	000
04260280182070	K160138	000
04260280182063	K160138	000
04260280183510	K160138	000
04260280181875	K160138	000
04260280180366	K160138	000
04260280182889	K160138	000
06970341677244	K160138	000
06970341677220	K160138	000
06970341677190	K160138	000
06970341677237	K160138	000
06970341677176	K160138	000
06970341674236	K160138	000
06970341670139	K160138	000
06970341670122	K160138	000
06970341670436	K160138	000
06970341670443	K160138	000
00853177007149	K160138	000
00853177007132	K160138	000
00853177007125	K160138	000
00853177007118	K160138	000
00853177007101	K160138	000
00853177007095	K160138	000
00853177007088	K160138	000
00850706007199	K160138	000
00853177007156	K160138	000
00857771003316	K160138	000
00815290015944	K160138	000
00815290015913	K160138	000
00815290015869	K160138	000
00815290015524	K160138	000
00815290015517	K160138	000
00815290015463	K160138	000
00815290015432	K160138	000
00815290015364	K160138	000
00850706007175	K160138	000
00850706007168	K160138	000
06970341674229	K160138	000
06970341674212	K160138	000
06970341674205	K160138	000
06970341674175	K160138	000
06970341677138	K160138	000
06970341674700	K160138	000
06970341677619	K160138	000
06970341674625	K160138	000
06970341674366	K160138	000
06970341674458	K160138	000
00850706007144	K160138	000
00850706007137	K160138	000
00850706007120	K160138	000
06970341677152	K160138	000
06970341677596	K160138	000
06970341677589	K160138	000
06970341677558	K160138	000
06970341674595	K160138	000
00815290016125	K160138	000