GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM

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 Gmdasz Tens Electrodes, Models Cwn1005, Dia. 5cm, Dwn2505, 5cmx5cm, Cwn1007.dia. 7cm, Cwn2509,5cmx9cm.

Pre-market Notification Details

• Device ID: K092546
• 510k Number: K092546
• Device Name: GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
• Classification: Electrode, Cutaneous
• Applicant: GMDASZ MANUFACTURING CO., LTD 77325 JOYCE WAY Echo, OR 97826
• Contact: Charlie Mack
• Correspondent: Charlie Mack; GMDASZ MANUFACTURING CO., LTD 77325 JOYCE WAY Echo, OR 97826
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-19
• Decision Date: 2009-12-18
• Summary: summary

NIH GUDID Devices

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