FDA.reportPublic FDA data

Vector Elite

Primary DI
00815962020269
Brand
Vector Elite
Company
BIONESS INC.
Model
VEC-1000
Device description
Vector Gait and Safety System
Published
2017-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXBEXERCISER, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815962020269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815962020269008159620202698159620202690815962020269

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation system harnessA lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)211-9136info@bioness.com

Regulatory Flags#

DUNS number
182287727
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815962021464StimRouter User KitST2-50502022-10-17
00815962020528H200 Wireless SystemH2W-53002019-08-08
00815962020535H200 Wireless SystemH2W-52002019-08-08
00815962020542H200 Wireless SystemH2W-55002019-08-08
00815962020559H200 Wireless SystemH2W-54002019-08-08
00815962020566H200 Wireless SystemH2W-40002019-08-08
00815962020573H200 Wireless SystemH2W-41002019-08-08
00815962020580H200 Wireless SystemH2W-51002019-08-08
00815962020597H200 Wireless SystemH2W-50002019-08-08
00815962020603H200 Wireless SystemH2W-47002019-08-08
07290110482008NESS H200® Wireless Hand Rehabilitation SystemH2W-5300501-00037-012017-02-02
07290110482015NESS H200® Wireless Hand Rehabilitation SystemH2W-5200501-00038-012017-02-02
07290110482022NESS H200® Wireless Hand Rehabilitation SystemH2W-5500501-00041-012017-02-02
07290110482039NESS H200® Wireless Hand Rehabilitation SystemH2W-5400501-00042-012017-02-02
07290110482046NESS H200® Wireless Hand Rehabilitation SystemH2W-4000501-00094-012017-02-02
07290110482053NESS H200® Wireless Hand Rehabilitation SystemH2W-4100501-00095-012017-02-02
07290110482060NESS H200® Wireless Hand Rehabilitation SystemH2W-5100501-00120-012017-02-02
07290110482077NESS H200® Wireless Hand Rehabilitation SystemH2W-5000501-00121-012017-02-02
07290110482084NESS H200® Wireless Hand Rehabilitation SystemH2W-4700501-00176-012017-02-02
00815962020290H200 WirelessH2W-SW012018-02-08

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