FDA.reportPublic FDA data

Aretech Premium Harness

Primary DI
00850018836081
Brand
Aretech Premium Harness
Company
ARETECH, LLC
Model
AH-0P
Device description
"Size: Pediatric (waist circumference measured 2"" below belly button: 22 - 26 inches). The Aretech Premium Harness is designed for use with Aretech products."
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
00850018836081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018836081008500188360818500188360810850018836081

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation system harnessA lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.

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

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
00850018836067ZeroG-Passive SystemZGP-1102021-09-24
00850018836074Aretech Premium HarnessAH-0T2021-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00689281037464PLUS Shampoo Shelf 24 + Grab Bar, Brushed StainlessHealthcraft Products Inc.IKX2026-09-22
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
06975996304064Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304071Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304088Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304095Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
06975996304101Assist RailsGuangdong Xiangyuanheng Medical Technology Co., Ltd.IKX2026-09-21
00810226441989ViveVIVE HEALTH LLCIKX2026-08-14
06974021419490EQUATEWAL-MART STORES, INC.IKX2026-07-31
10194484320772CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
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