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510(k) K243320

Air Pressure Therapy System (VU-IPC04B) by Xiamen Weiyou Intelligent Technology Co., Ltd. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2024
Date Received
October 23, 2024
Clearance Type
Special
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 Xiamen Weiyou Intelligent Technology Co., Ltd.

  • K243791 — Air Pressure Therapy System (January 13, 2025)
  • K233238 — Air Pressure Therapy System (Model:VU-IPC4M) (June 14, 2024)
  • K201935 — Air Pressure Therapy System (June 22, 2021)
  • K210967 — Air Pressure Therapy System: VU-IPC06 (May 11, 2021)

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)
  • K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM6 (April 25, 2025)