AccessGUDID - DEVICE: THERA-Trainer balo (04041925002713)

GUDID

Device Identifier (DI) Information

Brand Name: THERA-Trainer balo
Version or Model: 01.XX.XX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: medica - Medizintechnik GmbH

Primary DI Number: 04041925002713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328011325 *Terms of Use

Device Description: THERA-Trainer balo 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 balo 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba756601-6a4b-4c6f-bc4c-b1713a7157a4
Public Version Date: October 31, 2023
Public Version Number: 1
DI Record Publish Date: October 23, 2023