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510(k) K130722

AIRCAST VENAFLOW ELITE SYSTEM by Djo, LLC — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2013
Date Received
March 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Djo, LLC

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  • K170918 — Compex Sport Elite (June 20, 2017)
  • K170903 — Compex Wireless USA (June 19, 2017)
  • K153704 — Strive (June 3, 2016)
  • K153696 — Chattanooga Revolution Wireless (April 14, 2016)
  • K153224 — VitalStim(R) Plus Electrotherapy System (February 17, 2016)
  • K143551 — Compex Wireless USA (April 28, 2015)
  • K132284 — VECTRA NEO CLINICAL THERAPY SYSTEM (April 10, 2014)
  • K124016 — EMPI PHOENIX (May 6, 2013)
  • K122499 — AIRCAST VENAFLOW ELITE SYSTEM (October 18, 2012)

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  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)