Luminaire BWS Treadmill System

Primary DI
00850018836272
Brand
Luminaire BWS Treadmill System
Company
ARETECH, LLC
Model
LU-001
Device description
Luminaire is a robotic body-weight support system fixed above a slat-belt treadmill. The system provides precise levels of dynamic body-weight support to the patient as they walk on the treadmill, while simultaneously preventing falls. Clinician seating and footplates can be used for situations where manual-assisted ambulation is desired. The Luminaire System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice ambulating on a treadmill. Luminaire should never be used to lift subjects and should never be connected to inanimate objects. Luminaire should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the Luminaire training competency exam conducted by an Aretech trainer or a certified staff trainer.
Published
2024-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850018836272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018836272008500188362728500188362720850018836272

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation frame, electricAn electrically-powered, body-weight unloading, gait rehabilitation device designed to assist a patient with a walking/balance disability (neurogenic, muscular, or osseous in origin) regain lost motor function, by enabling them to hang in a dedicated harness in a vertical position and exercise (e.g., walk over the ground or moving surface of an elliptical/treadmill, climb stairs, perform sit-to-stand movements). It consists of a ceiling- or wall-mounted beam, or floor-standing frame with a motorized attachment assembly connected to the harness which supports the body weight. It is intended to be used in a clinical setting under professional supervision.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)710-0370info@aretechllc.com

Regulatory Flags#

DUNS number
825904738
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018836258BabyG Early Mobilization SystemBG-0012024-04-01
00850018836265ZeroG 3D 3-Dimensional BWS SystemZG3D-0012024-04-01
00850018836012ZeroG Gait & Balance SystemZGGB-V32021-09-24
00850018836029Ovation 400OV-4002021-09-24
00850018836043Ovation 700OV-7002021-09-24
00850018836067ZeroG-Passive SystemZGP-1102021-09-24
00850018836074Aretech Premium HarnessAH-0T2021-09-24
00850018836081Aretech Premium HarnessAH-0P2021-09-24
00850018836098Aretech Premium HarnessAH-XS2021-09-24
00850018836104Aretech Premium HarnessAH-0S2021-09-24
00850018836111Aretech Premium HarnessAH-0M2021-09-24
00850018836128Aretech Premium HarnessAH-0L2021-09-24
00850018836135Aretech Premium HarnessAH-XL2021-09-24
00850018836142Aretech Premium HarnessAH-2XL2021-09-24
00850018836159Aretech Premium HarnessAH-3XL2021-09-24
00850018836234ZeroG-Lite Treadmill SystemZGL-V32021-09-24

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