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510(k) K203498

LX9max by Daesung Maref Co., Ltd. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2021
Date Received
November 27, 2020
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.

  • K231437 — LF900 (July 19, 2023)
  • K202395 — SP-1000, SP-2000 (September 1, 2021)
  • 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)
  • K150033 — Air Compressible Limb Therapy System (April 20, 2015)

Other clearances for product code IRP

  • K252386 — Hot and Cold Compression System (A02-C-032) (April 3, 2026)
  • K253076 — Cryopush Cold Compression Device (A02-P-001) (April 2, 2026)
  • 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)