OmniStand

Basic Information

• Brand Name: OmniStand
• Primary DI: 04041925002805
• Version / Model: A000-509
• Company Name: medica - Medizintechnik GmbH
• Labeler DUNS: 328011325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-01
• Public Version: 2
• Public Version Date: 2023-10-11
• Public Version Status: Update
• Public Device Record Key: 7cb6e35c-0aa9-4811-a2fb-dd63cb4c16db

Device Description

Exerciser, non-measuring for stroke rehabilitation

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66037	Standing balance frame	A non-powered, frame-like device intended to help provide hands-free support for a standing patient during rehabilitative standing practice and exercise under clinician supervision. It consists of a standing platform and superstructure frame with a knee support rail against which the knee/lower leg can be placed to prevent the knee giving way. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04041925002805	GS1

Customer Contacts

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