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FDA 510(k)

WANDY SELF-ADHESIVE ELECTRODES

K-Number: K132998 · 2013-12-20

ApplicantWandy Rubber Industrial Co., Ltd.
Decision Date2013-12-20
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WANDY SELF-ADHESIVE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Wandy Rubber Industrial Co., Ltd.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132998. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WANDY SELF-ADHESIVE ELECTRODES?

WANDY SELF-ADHESIVE ELECTRODES is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Wandy Rubber Industrial Co., Ltd.. The 510(k) number is K132998.

When did WANDY SELF-ADHESIVE ELECTRODES receive FDA 510(k) clearance?

WANDY SELF-ADHESIVE ELECTRODES received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132998.

Who is the listed applicant for WANDY SELF-ADHESIVE ELECTRODES?

The FDA 510(k) record lists Wandy Rubber Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WANDY SELF-ADHESIVE ELECTRODES?

The FDA product code for WANDY SELF-ADHESIVE ELECTRODES is GXY.

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Other records listing Wandy Rubber Industrial Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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