AccessGUDID - DEVICE: Bioness Integrated Therapy System, BITS 3.0, BITS Balance (00815962020610)

GUDID

Device Identifier (DI) Information

Brand Name: Bioness Integrated Therapy System, BITS 3.0, BITS Balance
Version or Model: BITS-3055
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIONESS INC.

Primary DI Number: 00815962020610
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 182287727 *Terms of Use

Device Description: Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
30908	Perceptual-coordination assistive training device	A device designed to help train a person with a disability to improve their ability to correctly process and coordinate external stimuli, especially those relating to concepts of space and time, spatial concepts, and eye-hand coordination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PTY	Computerized cognitive assessment aid, exempt
ISD	Exerciser, measuring
IKK	SYSTEM, ISOKINETIC TESTING AND EVALUATION

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
Storage Environment Temperature: between -40 and 176 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f7fa0eb-b7a0-46bb-8d91-780f9e4544be
Public Version Date: August 18, 2020
Public Version Number: 1
DI Record Publish Date: August 10, 2020