Singapore HSA registration DE0508576
g.tec recoveriX PRO
Singapore·CLASS B·g.tec medical engineering GmbH·Registered October 17, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0508576
- Registration Date
- October 17, 2023
- Change Notification Approval Date
- December 20, 2024
- Retention Due Date
- October 16, 2025
Product description
Intended use recoveriX PRO is intended • for muscle re-education by powered muscle stimulation and • for neurofeedback The indication for use of recoveriX PRO for muscle stimulation is given when the extensor digitorum communis muscles of the lower arms that are partly or fully paralyzed due to stroke should be contracted to generate movement.
Product Owner
- Short Name
- g.tec medical engineering GmbH
- Address
- Sierningstraße 14 4521 Schiedlberg, AUSTRIA
Registrant
- Address
- 50 SERANGOON NORTH AVENUE 4, FIRST CENTRE, #05-14, SINGAPORE 555856
Importer
- Address
- 3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #07-21, SINGAPORE 159471
Model information
- Model Name(s)
- g.GAMMAgel stimulation electrodes stimulation electrodes large g.Estim FES g.GAMMAcap2 for g.Nautilus PRO, Size L, 2mm g.GAMMAcap2 for g.Nautilus PRO, Size M, 2mm g.GAMMAcap2 for g.Nautilus PRO, Size S, 2mm g.Nautilus PRO 32 Flexible g.Nautilus PRO 16 Flexible g.Nautilus PRO 8 Flexible recoveriX PRO hand therapy
- Model Identifier(s)
- 1021 1164 1168 1170 5300L_2 5300M_2 5300S_2 5700PRO 5710PRO 5720PRO 6400PRO
About this record
Access comprehensive regulatory information for g.tec recoveriX PRO in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508576 and owned by g.tec medical engineering GmbH. The device was registered on October 17, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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