Well-Life Garment Electrodes (GM Series)
FDA 510(k) K200942 · Well-Life Healthcare Limited
510(k) numberK200942
Submission
- Device name
- Well-Life Garment Electrodes (GM Series)
- Applicant
- Well-Life Healthcare Limited
New Taipei City, TW - Received
- April 8, 2020
- Decision date
- June 1, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Well-Life Garment Electrodes (GM Series) cleared by the FDA?
Well-Life Garment Electrodes (GM Series) (K200942) received a 510(k) decision of Substantially Equivalent on June 1, 2021, 419 days after the submission was received.
What is the product code of K200942?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.