OmnisEMG

Basic Information

• Brand Name: OmnisEMG
• Primary DI: B179OMNI13E87E4
• Version / Model: 44144
• Company Name: ACCELERATED CARE PLUS CORP
• Labeler DUNS: 828331616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-06
• Public Version: 1
• Public Version Date: 2023-09-14
• Public Version Status: New
• Public Device Record Key: b708bd16-e382-4bf0-a6bc-e9fa4c9c5319

Device Description

Biomechanical function analysis / interactive rehabilitation system

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
HCC	Device, Biofeedback	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63312	Biomechanical function analysis/interactive rehabilitation system	A computerized device assembly designed for: 1) analysis of biomechanical/neuromuscular function using dedicated hardware; and 2) neuromuscular rehabilitation therapy at multiple anatomical sites based on patient interaction with dedicated physical-response measuring hardware (e.g., dynamometer, standing force plates, EMG electrodes) providing feedback in a videogame-like format. It includes multiple pieces of neuromuscular function analysis and physical-response measuring hardware, computer interface devices and dedicated software; it is intended to be used with an off-the-shelf computer. It is not based on tracking movement through space (i.e., not a virtual-display rehabilitation system).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B179OMNI13E87E4	HIBCC

Customer Contacts

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