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510(k) K200942

Well-Life Garment Electrodes (GM Series) by Well-Life Healthcare Limited — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2021
Date Received
April 8, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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  • K123075 — BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413 (July 11, 2013)

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