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Compressible Limb and Circulation Therapy System

by Won Industrial Co.

510(k) K120166

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120166 Date14 May 2012ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0205-2018 FDA Class II initiated 13 Jan 2017
    • Terminated Z-0204-2018 FDA Class II initiated 13 Jan 2017

    Distribution of unapproved devices with incorrect air compression level setup

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IRP
Device Class
Class II
Regulation
21 CFR Part 890.5650
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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