Bioness Integrated Therapy System, BITS 3.0, BITS Balance

GUDID 00815962020627

BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit

BIONESS INC.

Perceptual-coordination assistive training device

• Primary Device ID: 00815962020627
• NIH Device Record Key: 4571625c-b9d4-41db-ac55-8aeaada2c0c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioness Integrated Therapy System, BITS 3.0, BITS Balance
• Version Model Number: BITS-3155
• Company DUNS: 182287727
• Company Name: BIONESS INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 176 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020627 [Primary]

FDA Product Code

• IKK: SYSTEM, ISOKINETIC TESTING AND EVALUATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-18
• Device Publish Date: 2020-08-10

On-Brand Devices [Bioness Integrated Therapy System, BITS 3.0, BITS Balance]

• 00815962020627: BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
• 00815962020610: Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BIT