HUBER360

Basic Information

• Brand Name: HUBER360
• Primary DI: B534HUBER360MDEVO1
• Version / Model: HUBER 360 EVOLUTION
• Company Name: L P G SYSTEMS
• Labeler DUNS: 394430433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-02
• Public Version: 1
• Public Version Date: 2023-05-10
• Public Version Status: New
• Public Device Record Key: 4f3502c7-c79a-4a60-9d73-8a57e45e316b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	890.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33599	Prone scooter board	A device designed to be used by a person with a disability or a patient to assist them in the training of their upper limbs and the muscles of the neck and back extensors. It consists of a board (usually with a raising chest piece) mounted on caster wheels that permits the person/patient to lie in a prone position and to elevate their head and shoulders. The device offers a non-ambulatory person/patient an alternative position to sitting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B534HUBER360MDEVO1	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity