Ovation 400

Primary DI
00850018836029
Brand
Ovation 400
Company
ARETECH, LLC
Model
OV-400
Device description
The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 400 model allows for a patient weight capacity of up to 400 pounds with a dynamic body-weight support range of 10 to 200 pounds.
Published
2021-09-24
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
00850018836029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018836029008500188360298500188360290850018836029

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
00850018836272Luminaire BWS Treadmill SystemLU-0012024-04-01
00850018836012ZeroG Gait & Balance SystemZGGB-V32021-09-24
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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