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510(k) K250046

Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) by Shenzhen Urion Technology Co., Ltd. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2025
Date Received
January 10, 2025
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 Shenzhen Urion Technology Co., Ltd.

  • K243115 — Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, (February 21, 2025)
  • K241007 — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (October 24, 2024)
  • K200802 — Infrared Thermometer (October 7, 2020)
  • K160019 — U80 Series Upper Arm Electronic Blood Pressure Monitor (April 22, 2016)
  • K141683 — ELECTRONIC BLOOD PRESSURE MONITOR (April 3, 2015)

Other clearances for product code IRP

  • 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)
  • K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (May 5, 2025)
  • K242140 — Air Compression Leg Massager (K-705) (March 17, 2025)