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510(k) K230500

Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) by Jiangsu Maxf Electric Appliance Co., Ltd. — Product Code IRP

K230500 is an FDA 510(k) premarket notification submitted by Jiangsu Maxf Electric Appliance Co., Ltd. for the device "Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)". The FDA issued a decision of Substantially Equivalent on October 26, 2023. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2023
Date Received
February 24, 2023
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 for product code IRP

  • K253919 — Cryo And Thermo Therapy System (June 10, 2026)
  • 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)

FDA data resources