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510(k) K122499

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2012
Date Received
August 16, 2012
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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  • 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)
  • K130722 — AIRCAST VENAFLOW ELITE SYSTEM (June 20, 2013)
  • K124016 — EMPI PHOENIX (May 6, 2013)

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  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
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