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510(k) K202108

External Counterpulsation System, Soulaire by Vamed Medical Instrument Co., Ltd. — Product Code DRN

K202108 is an FDA 510(k) premarket notification submitted by Vamed Medical Instrument Co., Ltd. for the device "External Counterpulsation System, Soulaire". The FDA issued a decision of Substantially Equivalent on August 28, 2020. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Vamed Medical Instrument Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2020
Date Received
July 30, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

Other clearances by Vamed Medical Instrument Co., Ltd.

  • K190683 — External Counterpulsation System (September 10, 2019)

Other clearances for product code DRN

  • K250756 — Pression Wave PRO External Counter-Pulsation System (December 22, 2025)
  • K191955 — Enhanced External Counter Pulsation Device Plus Omay-A (August 5, 2020)
  • K190683 — External Counterpulsation System (September 10, 2019)
  • K173483 — Pure Flow External Counter-Pulsation Device (May 30, 2018)
  • K152115 — Renew NCP-5 External Counterpulsation System (December 17, 2015)
  • K130439 — EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING (December 12, 2013)
  • K082134 — CIRCULATOR BOOT (May 7, 2009)
  • K081359 — GENESIS ECP (May 29, 2008)
  • K052611 — ECP HEALTH SYSTEM, MODEL 2005 (April 26, 2006)
  • K050172 — CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (March 31, 2005)

FDA data resources