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510(k) K112441

COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM by Daesung Maref Co., Ltd. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2012
Date Received
August 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type

Other clearances by Daesung Maref Co., Ltd.

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  • K203019 — LF900 (June 22, 2021)
  • K203353 — DVT-PRO (April 22, 2021)
  • K203417 — DVT-4000S (March 28, 2021)
  • K203016 — DVT-2600 (December 5, 2020)
  • K160178 — Lympha-Flow(LF1200) (January 11, 2017)
  • K160180 — Intermittent Pneumatic Compression system (November 3, 2016)
  • K150980 — Venous Assist System (May 12, 2016)

Other clearances for product code IRP

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  • K251622 — Hand Massager (SM004D) (January 28, 2026)
  • K251662 — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505) (November 13, 2025)
  • K251531 — AIR COMPRESSION BOOTS 1018195,1018196 (October 30, 2025)
  • K253150 — Cryon-X Cold Compression (October 24, 2025)
  • K251905 — Normatec Elite Hip (September 18, 2025)
  • K251623 — Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (September 17, 2025)
  • K250244 — Compression Therapy Device (LGT-2210DS) (July 25, 2025)
  • K242615 — Intermittent pressure compression system (Compression Pump PT1005A; Leg Compress (July 23, 2025)