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510(k) K223541

Cold/Hot Compression by Jkh Health Co., Ltd. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
November 25, 2022
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 Jkh Health Co., Ltd.

  • K253150 — Cryon-X Cold Compression (October 24, 2025)
  • K240788 — Ultrasound Stimulator (June 4, 2025)
  • K240986 — Cold Compression (May 1, 2024)
  • K240011 — Lymphedema Compression (February 23, 2024)
  • K211050 — Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 (November 28, 2022)
  • K202839 — Overlapped Compression Therapy (January 21, 2021)
  • K200561 — StimPlus Patch, StimPlus Patch, StimPlus Patch (July 1, 2020)
  • K162517 — Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (April 14, 2017)
  • K153520 — Electronic Pulse Stimulator (May 5, 2016)

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)