Izar™ is intended to rehabilitate hand functions such as dexterous grasp, pinch, and grip, as well as wrist movements in adult patients with hand motor function impairment. This therapy…
Izar™ is intended to rehabilitate hand functions such as dexterous grasp, pinch, and grip, as well as wrist movements in adult patients with hand motor function impairment. This therapy device can be used as a controller for various activities allowing the patient to train within a therapy session and also alone to increase total therapy dose. The device can be used in all the environments the patient navigates; hospital, clinic, private practice, and at home.
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Izar™ | Listed by | NeuroXtherapeutics SA, Switzerland |
| FDA product code | JFA |
| Device type | Exerciser, Finger, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5410 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-23 |
| Record revised | 2026-03-10 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 30 °C; Storage environment humidity 5 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.