Ovation 400

GUDID 00850018836029

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.

ARETECH, LLC

Gait rehabilitation frame, electric
Primary Device ID00850018836029
NIH Device Record Key7614db3e-b025-4b57-89f4-785369ad1d0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvation 400
Version Model NumberOV-400
Company DUNS825904738
Company NameARETECH, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com
Phone(800) 710-0370
Emailinfo@aretechllc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018836029 [Primary]

FDA Product Code

BXBExerciser, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-24

Devices Manufactured by ARETECH, LLC

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00850018836012 - ZeroG Gait & Balance System2021-10-04 The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they
00850018836029 - Ovation 4002021-10-04The 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.
00850018836029 - Ovation 4002021-10-04 The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice the
00850018836043 - Ovation 7002021-10-04 The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice the
00850018836067 - ZeroG-Passive System2021-10-04 The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic a
00850018836074 - Aretech Premium Harness2021-10-04 Size: Toddler (waist circumference measured 2" below belly button: 20 - 23 inches). The Aretech Premium Harness is designed for

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