FDA.reportPublic FDA data

ZeroG-Passive System

Primary DI
00850018836067
Brand
ZeroG-Passive System
Company
ARETECH, LLC
Model
ZGP-110
Device description
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.
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
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018836067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018836067008500188360678500188360670850018836067

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation frame, manualA manually-operated, 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 manual 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

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
00850018836029Ovation 400OV-4002021-09-24
00850018836043Ovation 700OV-7002021-09-24
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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Primary DI, Brand, Company table
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00689281037471PLUS Shampoo Shelf 24 + Grab Bar, Chrome PolishedHealthcraft Products Inc.IKX2026-09-22
00689281039598PLUS Shampoo Shelf 24 + Grab Bar, Oil Rubbed BronzeHealthcraft Products Inc.IKX2026-09-22
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06975996304101Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
00810226441989ViveVIVE HEALTH LLCIKX2026-08-14
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