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FDA 510(k)

Well-Life Garment Electrodes (GM Series)

K-Number: K200942 · 2021-06-01

ApplicantWell-Life Healthcare Limited
Decision Date2021-06-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Well-Life Garment Electrodes (GM Series) is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2021-06-01 under 510(k) number K200942. 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 Well-Life Garment Electrodes (GM Series)?

Well-Life Garment Electrodes (GM Series) is a medical device that received FDA 510(k) clearance on 2021-06-01. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K200942.

When did Well-Life Garment Electrodes (GM Series) receive FDA 510(k) clearance?

Well-Life Garment Electrodes (GM Series) received FDA 510(k) clearance on 2021-06-01, under 510(k) number K200942.

Who is the listed applicant for Well-Life Garment Electrodes (GM Series)?

The FDA 510(k) record lists Well-Life Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well-Life Garment Electrodes (GM Series)?

The FDA product code for Well-Life Garment Electrodes (GM Series) is GXY.

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Other records listing Well-Life Healthcare Limited as applicant

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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

View on FDA Database →

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

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