MCU Multi-Cervical Unit

Basic Information

• Brand Name: MCU Multi-Cervical Unit
• Primary DI: 10850390007427
• Version / Model: MCU 2
• Company Name: BTE TECHNOLOGIES, INC.
• Labeler DUNS: 021461470
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 4
• Public Version Date: 2020-05-13
• Public Version Status: Update
• Public Device Record Key: 5925ab4b-1df1-4958-8b7f-9a928fa5fc71

Device Description

A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes.

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: Yes
• 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
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	890.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35699	Neck mechanical weight exerciser	A mechanical exercise apparatus intended primarily to strengthen the major muscles of the neck (e.g., sternocleidomastoid, splenius capitis and cervicis/colli) through repetitive flexion or extension of the neck muscles against the force of a weight. It typically consists of a metal frame containing a lever or pulley-cable system that may incorporate changeable weights and a head pad or head/neck harness; a bench may be included for the user to sit while performing the exercise. The device may also be used to improve neck flexibility and mobility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850390007427	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 55 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 55 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius