THERA-Trainer coro

Basic Information

• Brand Name: THERA-Trainer coro
• Primary DI: 04041925002720
• Version / Model: 02.XX.XX
• Company Name: medica - Medizintechnik GmbH
• Labeler DUNS: 328011325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-23
• Public Version: 1
• Public Version Date: 2023-10-31
• Public Version Status: New
• Public Device Record Key: 946d19c8-f586-4722-bb1d-64bf8f6af664

Device Description

THERA-Trainer coro is a standing aid with balance function, suitable for static-dynamic training of patients with limited standing capacity. Safe standing and balance are important requirements for walking. THERA-Trainer coro offers patients a safe environment during training based on a stable frame that supports the patient at the hips and optionally at the knees to practice standing and balancing without any danger and fear of falling. A mechanical adjustment function makes it possible to switch from static to dynamic standing training. In dynamic, balancing training the frame relies on a set of springs that offer a dynamic resistance to upper body movement while still ensuring a safe environment preventing falls.

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
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13964	Physical therapy table, non-powered	A dedicated device specifically designed for use in physical therapies. It is a non-powered device that has manually-adjustable table top functions for height and position, including vertical tilting from supine to upright. It will typically incorporate foot supports, straps and exercisers (e.g., pulleys or rotators, arm slings, and leg exercisers). This device is designed for treatment of diseases using therapeutic exercises and massage, e.g., to enhance blood circulation to the lower limbs in patients with neurological disorders (e.g., spinal cord injury) and also to aid in muscle training and sense of balance.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04041925002720	GS1