IRP — Massager, Powered Inflatable Tube Class II

FDA Device Classification

Classification Details

Product Code
IRP
Device Class
Class II
Regulation Number
890.5650
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251622ningbo zhenhai yihao electronic technology coHand Massager (SM004D)January 28, 2026
K251662shenzhen future electronic coAir Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505)November 13, 2025
K251531merchsourceAIR COMPRESSION BOOTS 1018195,1018196October 30, 2025
K253150jkh health coCryon-X Cold CompressionOctober 24, 2025
K251905normatec industriesNormatec Elite HipSeptember 18, 2025
K251623shenzhen yicai health technology coAir Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)September 17, 2025
K250244guangzhou longest medical technology coCompression Therapy Device (LGT-2210DS)July 25, 2025
K242615xiamen taotao technology coIntermittent pressure compression system (Compression Pump PT1005A; Leg CompressJuly 23, 2025
K242754zamar medicalZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)May 5, 2025
K250046shenzhen urion technology coAir Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM6April 25, 2025
K242140jiale health technology shenzhen coAir Compression Leg Massager (K-705)March 17, 2025
K243206sichuan qianli-beoka medical technologyAir compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACFebruary 19, 2025
K243572avanos medicalGame Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready January 31, 2025
K243791xiamen weiyou intelligent technology coAir Pressure Therapy SystemJanuary 13, 2025
K243177elastimedSACS PRODecember 23, 2024
K232965shenzhen ruiyi business technology coLeg Massager (Models:RP-ALM070H, RP-ALM071H)November 20, 2024
K243320xiamen weiyou intelligent technology coAir Pressure Therapy System (VU-IPC04B)November 18, 2024
K242940shenzhen xinrun electric appliances coXrecovery (XR-001)November 14, 2024
K241446sichuan qianii-beoka medical technoiogy lncAir Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)October 8, 2024
K240373zhangzhou easepal medical science and technology coAir compression Leg Massager (MM0520, MM0521, MM0522)September 17, 2024