Home / 510(k) Clearances / K210166

510(k) K210166

Omnispec ED1000 by Medispec, Ltd. — Product Code ISA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2023
Date Received
January 21, 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 Medispec, Ltd.

  • K063504 — ECONOLITH EM1000 (March 9, 2007)
  • K040461 — ECONOLITH E3000, MODEL 3000 (SW-6) (May 25, 2004)
  • K974796 — LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER (March 12, 1998)

Other clearances for product code ISA

  • K243488 — VMAT PRO (February 6, 2025)
  • K240358 — ShockPhysio Mobile (model SW3200 Basic) (June 5, 2024)
  • K221865 — BTL-094 (April 14, 2023)
  • K213120 — OW100S (model OW100S-US) (October 12, 2022)
  • K220538 — DolorClast Radial (July 11, 2022)
  • K210451 — OrthoGold 100 (May 5, 2021)
  • 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)