Home / 510(k) Clearances / K253919

510(k) K253919

Cryo And Thermo Therapy System by Xiamen Weiyou Intelligent Technology Co., Ltd. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2026
Date Received
December 8, 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 Xiamen Weiyou Intelligent Technology Co., Ltd.

  • K253064 — Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); (April 30, 2026)
  • K243791 — Air Pressure Therapy System (January 13, 2025)
  • K243320 — Air Pressure Therapy System (VU-IPC04B) (November 18, 2024)
  • 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

  • K252396 — Cryo Sport 2.0 (AVA 501) (May 29, 2026)
  • K254200 — Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT0 (May 5, 2026)
  • K253064 — Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); (April 30, 2026)
  • 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)