Vector Elite

GUDID 00815962020269

Vector Gait and Safety System

BIONESS INC.

Gait rehabilitation system harness
Primary Device ID00815962020269
NIH Device Record Key7820fdeb-f6ae-4c68-b122-8f790ca948f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVector Elite
Version Model NumberVEC-1000
Company DUNS182287727
Company NameBIONESS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com
Phone+1(800)211-9136
Emailinfo@bioness.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100815962020269 [Primary]

FDA Product Code

BXBEXERCISER, POWERED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-07

On-Brand Devices [Vector Elite]

00815962020276Vector Trolley Assembly, Elite Model
00815962020269Vector Gait and Safety System

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