WANDY SELF-ADHESIVE ELECTRODES

Electrode, Cutaneous

WANDY RUBBER INDUSTRIAL CO., LTD

The following data is part of a premarket notification filed by Wandy Rubber Industrial Co., Ltd with the FDA for Wandy Self-adhesive Electrodes.

Pre-market Notification Details

• Device ID: K132998
• 510k Number: K132998
• Device Name: WANDY SELF-ADHESIVE ELECTRODES
• Classification: Electrode, Cutaneous
• Applicant: WANDY RUBBER INDUSTRIAL CO., LTD NO. 48 LANE 392, FU TEH 1ST RD New Taipei City, TW 221
• Contact: Jack Yi
• Correspondent: Jack Yi; WANDY RUBBER INDUSTRIAL CO., LTD NO. 48 LANE 392, FU TEH 1ST RD New Taipei City, TW 221
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-24
• Decision Date: 2013-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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