Class A Ent.
Country not established
- Devices
- 3
What Class A Ent. makes
Class A Ent. manufactures disposable and reusable needle electrodes for electromyography (EMG) and electrodiagnostic testing, including monopolar EMG needles and detachable variants, as well as EEG electrodes for electroencephalogram recordings. Their product line includes single-use monopolar needle electrodes and reusable EMG needles designed for repeated use in clinical settings. The company also supplies disposable electrodes for EEG monitoring, which are used in neurological assessments.
The company’s devices are classified under FDA Class II, requiring premarket notification (510(k)) clearance. These products are listed in the FDA’s 510(k) database, indicating regulatory authorisation for commercial distribution in the United States. The manufacturer operates from the US, adhering to applicable US regulatory standards for medical devices.
Catalogue
Eeg Electrodes Model 445 Series Ref K982053
Regimes: 510(k) Registry: 510(k)Disposable Monopolar Needle Electrode Ref K912783
Regimes: 510(k) Registry: 510(k)Detachable Monopolar Emg Needle, Models 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 Ref K021118
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Class A Ent. have in the registry?
The registry currently lists 3 devices for Class A Ent.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Class A Ent.'s devices?
Among its 3 most recently registered devices, Class A Ent. has devices listed in FDA 510(k) (3 devices).
What risk classes do Class A Ent.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Class A Ent.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Class A Ent. in the registry?
The most recently registered devices listed for Class A Ent. include EEG ELECTRODES MODEL 445 SERIES, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE and DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570.