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510(k) K252386

Hot and Cold Compression System (A02-C-032) by Chengdu Cryo-Push Medical Technology Co.,Ltd — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2026
Date Received
July 31, 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 Chengdu Cryo-Push Medical Technology Co.,Ltd

  • K253076 — Cryopush Cold Compression Device (A02-P-001) (April 2, 2026)
  • K230524 — Cold Compression Wrap Pro (January 19, 2024)
  • K222669 — Cryopush Cold Compression Device (December 5, 2022)

Other clearances for product code IRP

  • 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)
  • K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (May 5, 2025)