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g.tec recoveriX PRO - HSA Registration DE0508576

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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CLASS B
DE0508576
g.tec recoveriX PRO
HSA Registration Number: DE0508576
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Product Description

Intended use recoveriX PRO is intended โ€ข for muscle re-education by powered muscle stimulation and โ€ข 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.

Device 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 Owner
Short Name
g.tec medical engineering GmbH
Address
SierningstraรŸe 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