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510(k) K210451

OrthoGold 100 by Tissue Regeneration Technologies, LLC — Product Code ISA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2021
Date Received
February 16, 2021
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

Other clearances by Tissue Regeneration Technologies, LLC

  • K200926 — OrthoGold 100 (August 28, 2020)
  • K191961 — OrthoGold (November 26, 2019)
  • K182682 — OrthoGold 100 (December 21, 2018)
  • K062081 — LITHOGOLD (November 2, 2006)

Other clearances for product code ISA

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  • K240358 — ShockPhysio Mobile (model SW3200 Basic) (June 5, 2024)
  • K221865 — BTL-094 (April 14, 2023)
  • K210166 — Omnispec ED1000 (January 27, 2023)
  • K213120 — OW100S (model OW100S-US) (October 12, 2022)
  • K220538 — DolorClast Radial (July 11, 2022)
  • 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)