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510(k) K220538

DolorClast Radial by E.M.S Electro Medical Systems S.A — Product Code ISA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2022
Date Received
February 25, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Therapeutic, Electric
Device Class
Class I
Regulation Number
890.5660
Review Panel
PM
Submission Type

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  • K182490 — Swiss LithoClast Trilogy (October 9, 2018)
  • K181997 — Swiss LithoClast Trilogy (August 30, 2018)
  • K181364 — Swiss LithoClast Trilogy (June 20, 2018)
  • K173234 — Swiss LithoClast Trilogy (January 10, 2018)

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  • K182682 — OrthoGold 100 (December 21, 2018)
  • K173692 — D-Actor 200 Vibration Massage System (April 13, 2018)
  • K053225 — CELLU M6 KEYMODULE I (November 6, 2006)
  • K030876 — CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM (January 22, 2004)