BIOS Living

Basic Information

• Brand Name: BIOS Living
• Primary DI: 00057475571184
• Version / Model: 57118
• Company Name: Thermor Ltd
• Labeler DUNS: 246883458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-18
• Public Version: 1
• Public Version Date: 2023-09-26
• Public Version Status: New
• Public Device Record Key: e86df635-5861-41bc-959c-d7c27f492650

Device Description

Rehab Glider

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IOD	Components, Exercise	Physical Medicine	890.5350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63464	Lower limb sliding exerciser, non-powered	A non-powered device intended to encourage active movement of a patient’s lower limb(s) by assisting linear (or circular) movement of the foot, by flexion/extension at the knee, for rehabilitation and/or to help prevent deep vein thrombosis. It can be in the form of pad worn on the heel for sliding on a floor (or other smooth surface), or a frame with a moveable section placed on a bed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10057475571181	GS1	Case	4	In Commercial Distribution
Primary	00057475571184	GS1