Fasstech
Country not established
- Devices
- 9
What Fasstech makes
Fasstech manufactures electromyography (EMG) systems, including standalone and integrated units like the PSI 220 Dual EMG and FOCUS EMG, designed for muscle function assessment. Their portfolio also includes spinal stimulation devices such as the SPINAL TOUCH and neurodiagnostic platforms like the INSIGHT DISCOVERY, INSIGHT MILLENNIUM, INSIGHT MILLENNIUM III, and INSIGHT MILLENNIUM PLUS for neurological signal analysis. Additional offerings include the CWAS 1000, a device for compound muscle action potential studies, and the INSIGHT GENESIS for broader neurodiagnostic applications.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. These products are intended for use in clinical and research settings within the United States.
Catalogue
Insight Discovery Ref K063447
Regimes: 510(k) Registry: 510(k)Insight Millennium Iii Ref K023209
Regimes: 510(k) Registry: 510(k)Insight Millennium Plus Ref K011964
Regimes: 510(k) Registry: 510(k)Psi 220 Dual Emg Ref K925197
Regimes: 510(k) Registry: 510(k)Insight Genesis Ref K011983
Regimes: 510(k) Registry: 510(k)Cwas 1000 Ref K033452
Regimes: 510(k) Registry: 510(k)Spinal Touch Ref K961212
Regimes: 510(k) Registry: 510(k)Focus Emg Ref K940050
Regimes: 510(k) Registry: 510(k)Insight Millennium Ref K990778
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fasstech have in the registry?
The registry currently lists 9 devices for Fasstech. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fasstech's devices?
Among its 9 most recently registered devices, Fasstech has devices listed in FDA 510(k) (9 devices).
What risk classes do Fasstech's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Fasstech's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fasstech in the registry?
The most recently registered devices listed for Fasstech include INSIGHT DISCOVERY, INSIGHT MILLENNIUM III, INSIGHT MILLENNIUM PLUS and PSI 220 DUAL EMG.