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510(k) K081359

GENESIS ECP by Scottcare Corporation — Product Code DRN

K081359 is an FDA 510(k) premarket notification submitted by Scottcare Corporation for the device "GENESIS ECP". The FDA issued a decision of Substantially Equivalent on May 29, 2008. The device falls under product code DRN (Device, Counter-Pulsating, External), a Class II device regulated under 21 CFR 870.5225. Scottcare Corporation has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2008
Date Received
May 15, 2008
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 Scottcare Corporation

  • K250259 — TeleRehab Aermos Cardiopulmonary Rehabilitation (June 4, 2025)
  • K142180 — TELESENSE (December 12, 2014)
  • K092947 — TELESENTRY, MODEL TS01 (February 26, 2010)
  • K083382 — CHROMA, MODEL: RZ153C (August 13, 2009)

Other clearances for product code DRN

  • K250756 — Pression Wave PRO External Counter-Pulsation System (December 22, 2025)
  • K202108 — External Counterpulsation System, Soulaire (August 28, 2020)
  • 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)
  • K052611 — ECP HEALTH SYSTEM, MODEL 2005 (April 26, 2006)
  • K050172 — CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (March 31, 2005)

FDA data resources