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)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K230500 ↗

FDA Product Code

IRP

Device Class

Class II

Regulation

21 CFR Part 890.5650

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• What clinical settings is this device intended for, and how does it differ between those environments?

  The Air Compression Therapy Recovery System is designed for use in both clinical and home settings. In clinical environments, it is likely employed by healthcare providers to assist patients with temporary relief of minor muscle aches and pains, particularly after procedures or prolonged immobility. In home settings, it is intended for individual use to promote circulation and aid recovery from muscle strain or fatigue. The device’s reusable design and adjustable pressure settings make it versatile for both environments, though clinical use may involve additional supervision or protocols.

• Are the inflatable tubes and control unit part of the same reusable system, and how should they be maintained?

  Yes, the inflatable tubes and control unit are part of the same reusable system. Since the device is not specified to require sterilization, maintenance should focus on cleaning the inflatable tubes and control unit after each use to prevent bacterial buildup. Follow the manufacturer’s guidelines for proper disinfection, though specific instructions are not provided in the data. Regular inspection for wear and tear on the tubes is also recommended to ensure safe and effective operation.

• What are the key differences between the models, and how do they impact user experience?

  The models vary primarily by display type (LED or OLED) and pressure settings. For example, the MF-AWI.LED.A-801 and MF-AWI.OLED.A-601 differ in display technology, with OLED models likely offering clearer visual feedback. The pressure settings may vary between models (e.g., A-801 vs. B-801), allowing users to select intensity based on their needs. These distinctions impact user experience by offering customization in display clarity and pressure control, catering to preferences for visibility and comfort.

• Can this device be used safely during or after an MRI scan, and what precautions should be taken?

  The device is explicitly noted as having no MRI safety restrictions, meaning it does not contain metallic or ferromagnetic components that could interfere with MRI procedures. However, the inflatable tubes and control unit should not be brought into the MRI room itself, as the strong magnetic fields could pose a risk to the device or its components. Ensure the device is powered off and stored safely away from MRI equipment when not in use.

• How do I determine which model is best suited for my clinical or home use based on the available options?

  Choosing the right model depends on your preference for display technology and pressure customization. If you prioritize clear, energy-efficient visual feedback, OLED models (e.g., MF-AWI.OLED.A-601) may be preferable. For adjustable pressure settings, compare models labeled with ‘A’ or ‘B’ (e.g., MF-AWI.LED.A-801 vs. MF-AWI.LED.B-801) to select the intensity range that aligns with your patient or personal needs. Clinical settings may benefit from models with higher pressure options for therapeutic applications, while home users might prefer simpler, lower-pressure settings for comfort.