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
Substantially EquivalentJiangsu 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
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Recent devices under product code IRP
view all- K261887 — Normatec Elite Heat (6 models)
- K262812 — Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
- K260944 — ManaCold Compression System
- K260529 — Air Compression Massager (HY-1165)
- K260948 — Air Compression Massager (EP30B001 I)
Data sourced from openFDA. This site is unofficial and independent of the FDA.