Search Results
Found 1 results
510(k) Data Aggregation
K Number
K230500Device 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)
Manufacturer
Date Cleared
2023-10-26
(244 days)
Product Code
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu MaxF Electric Appliance Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Air Compression Therapy Recovery System (model: 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-A WI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
Device Description
The Air Compression Therapy Recovery System (model: 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) is a portable inflatable tube massage system which simulates kneading and stroking of leg, arm and hip by the use of inflatable air compression techniques. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.
The device utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and air valve. The pump, air valve and other components are protectively housed within the ABS plastic enclosure of the control unit.
The device consists of a control unit, two RecoveryLeg (air boot with attached hose connector), two RecoveryArm (air arm sleeve with attached hose connector) and one RecoveryPants (air pants with two attached hoses and hose connectors). The RecoveryLeg, RecoveryArm and RecoveryPants work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the boots, sleeves or pants to compress body.
The device is categorized to have long-term skin contact of greater than 30 days.
Environment of use of the device: Clinics, hospital, athlete training, and home environments.
Ask a Question
Ask a specific question about this device
Page 1 of 1