K230500
- 510(k) number
- K230500
- Device name
- 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)
- Applicant
- Jiangsu Maxf Electric Appliance Co., Ltd. CN
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2023-10-26
- Date received
- 2023-02-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K230500.pdf
Official FDA record: K230500
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.