IsoFlex LAL

IsoFlex LAL - 2860

Device Description

A large, durable, fabric case filled with various densities of foam that support a gel structure, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. This is a reusable device.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Handling Environment Humidity - Percent (%) Relative Humidity

100.00
10.00

Handling Environment Temperature - Degrees Fahrenheit

140.00
-40.00

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

100.00
10.00

Storage Environment Temperature - Degrees Fahrenheit

140.00
-40.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: IOQ

Device Name: Bed, Flotation Therapy, Powered

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: PM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 890.5170

Third Party Flag: N

Medical Specialty: PM

Device Identifiers

Device Id: 07613327286779

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A