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510(k) K221724

Conductive Gel by Tone-A-Matic International, Inc. — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2022
Date Received
June 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Tone-A-Matic International, Inc.

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  • K130052 — TONE-A-MATIC (December 20, 2013)

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  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
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  • K192606 — SAC2 - Electrode Cream (January 17, 2020)
  • K190050 — Tech Dots - Adhesive and conductive gel (July 19, 2019)