Biodex

Basic Information

• Brand Name: Biodex
• Primary DI: 00718175001486
• Version / Model: 950-148
• Catalog Number: 950-148
• Company Name: BIODEX MEDICAL SYSTEMS, INC.
• Labeler DUNS: 043833813
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-02
• Public Version: 1
• Public Version Date: 2023-08-10
• Public Version Status: New
• Public Device Record Key: 029b02ca-81f0-4395-9921-e1ec01abeb0a

Device Description

CYCLE, UPPER BODY - CLINICAL PRO

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: Yes
• Has Manufacturing Date: Yes
• 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
ISD	Exerciser, Measuring	Physical Medicine	890.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58500	Body flywheel exerciser	An exercise apparatus intended to strengthen several of the major muscle groups of the body (i.e., in the arms, legs, chest, back) through repetitive body motion against a flywheel. During the muscle contraction phase resistance is provided by the inertia of the flywheel, which is subsequently set spinning to provide resistance during the muscle lengthening phase. It typically consists of a floor-standing platform with a pulley, axle, and connection disc for the attachment of flywheel weights, with an assortment of harnesses, straps and grips. The device typically enables the performance of a wide variety of exercise motions including curls, presses, lunges and raises.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00718175001486	GS1