ZeroG-Passive System

GUDID 00850018836067

The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use.

ARETECH, LLC

Gait rehabilitation frame, manual
Primary Device ID00850018836067
NIH Device Record Keybf5c9a12-7843-4694-b13f-2c15d8b76d5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameZeroG-Passive System
Version Model NumberZGP-110
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 Datefalse
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
GS100850018836067 [Primary]

FDA Product Code

IKXAid, Transfer

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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00850018836272 - Luminaire BWS Treadmill System2024-04-09 Luminaire is a robotic body-weight support system fixed above a slat-belt treadmill. The system provides precise levels of dyna
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 4002021-10-04 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 System2021-10-04The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use.
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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