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)— 510(k) K230500

Name: FDA 510(k) clearance K230500
Creator: U.S. Food and Drug Administration
Published: 2023-10-26

Substantially Equivalent

Jiangsu Maxf Electric Appliance Co., Ltd.

FDA 510(k) clearance K230500 for 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), Substantially Equivalent on 2023-10-26. Applicant: Jiangsu Maxf Electric Appliance Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jiangsu Maxf Electric Appliance Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2023-02-24
Decision date: 2023-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.