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FDA 510(k)

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE

K-Number: K002219 · 2001-02-02

ApplicantWandy Rubber Industrial Co., Ltd.
Decision Date2001-02-02
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE 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 2001-02-02 under 510(k) number K002219. 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 NEUROSTIMULATION ELECTRODE?

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE is a medical device that received FDA 510(k) clearance on 2001-02-02. The listed applicant is Wandy Rubber Industrial Co., Ltd.. The 510(k) number is K002219.

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

WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE received FDA 510(k) clearance on 2001-02-02, under 510(k) number K002219.

Who is the listed applicant for WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE?

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 NEUROSTIMULATION ELECTRODE?

The FDA product code for WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE 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.

K132998WANDY SELF-ADHESIVE ELECTRODESK031174BODY SIGNAL ECG ELECTRODEK002227WANDY SILICONE CONDUCTIVE RUBBER PAD

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Official Source

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