| Primary Device ID | 00850018836265 |
| NIH Device Record Key | 2b456918-e270-463d-921a-034f8d7b4bb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZeroG 3D 3-Dimensional BWS System |
| Version Model Number | ZG3D-001 |
| Company DUNS | 825904738 |
| Company Name | ARETECH, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00850018836258 - BabyG Early Mobilization System | 2024-04-09 The BabyG Early Mobilization System is a robotic body-weight support system which automatically tracks patients as they move fre |
| 00850018836265 - ZeroG 3D 3-Dimensional BWS System | 2024-04-09ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The ZeroG 3D System is intended to assist subjects who have experienced neurological and orthopedic injures as they practice therapeutic activities related to walking and balance activities. ZeroG 3D can also be used to train subjects ambulating on a treadmill. ZeroG 3D should never be used to lift and transport subjects and should never be connected to inanimate objects. ZeroG 3D should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG 3D training competency exam conducted by an Aretech trainer or a certified staff trainer. |
| 00850018836265 - ZeroG 3D 3-Dimensional BWS System | 2024-04-09 ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The d |
| 00850018836272 - Luminaire BWS Treadmill System | 2024-04-09 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 System | 2021-10-04 The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they |
| 00850018836029 - Ovation 400 | 2021-10-04 The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice the |
| 00850018836043 - Ovation 700 | 2021-10-04 The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice the |
| 00850018836067 - ZeroG-Passive System | 2021-10-04 The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic a |
| 00850018836074 - Aretech Premium Harness | 2021-10-04 Size: Toddler (waist circumference measured 2" below belly button: 20 - 23 inches). The Aretech Premium Harness is designed for |