Vector Base

GUDID 00815962020283

Vector Gait and Safety System, Base Model

BIONESS INC.

Gait rehabilitation system harness

• Primary Device ID: 00815962020283
• NIH Device Record Key: 768c7658-1043-40f7-ab26-95d55ebf4e54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vector Base
• Version Model Number: VEC-3000
• Company DUNS: 182287727
• Company Name: BIONESS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020283 [Primary]

FDA Product Code

• BXB: EXERCISER, POWERED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-07

Devices Manufactured by BIONESS INC.

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• 00815962020627 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance: 2020-08-18 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
• 00815962020634 - BITS Motion Sensor: 2020-08-18 Bioness Integrated Therapy System Version 3.0 Motion Sensor
• 00815962020337 - L100 Go System: 2020-04-30 L100 Go System, Right
• 00815962020344 - L100 Go System: 2020-04-30 L100 Go System, Left
• 07290110482008 - NESS H200® Wireless Hand Rehabilitation System: 2019-11-08 H200 Wireless US System kit, Right Medium
• 07290110482015 - NESS H200® Wireless Hand Rehabilitation System: 2019-11-08 H200 Wireless US System kit, Left Medium