Teleemg, LLC
United StatesFDA applicant, unverified FDA FEI 3008881376
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Teleemg, LLC makes
Teleemg, LLC manufactures transcranial magnetic stimulation (TMS) systems, including standalone and cloud-connected devices designed for neurological and psychiatric applications. Their portfolio includes TMS solutions for obsessive-compulsive disorder (OCD) and modular systems like CloudTMS Edge, which integrates remote monitoring capabilities. These devices are intended for therapeutic interventions in clinical settings.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Teleemg, LLC operates from the United States.
Catalogue
Focus Emg Device Ref K102610
Regimes: 510(k) Registry: 510(k)Neurosoft TMS (also CloudTMS) Ref K173441
Regimes: 510(k) Registry: 510(k)CloudTMS for OCD Ref K221129
Regimes: 510(k) Registry: 510(k)CloudTMS Edge Ref K250689
Regimes: 510(k) Registry: 510(k)Neuro-Audio Ref K141524
Regimes: 510(k) Registry: 510(k)Neurosoft TMS Ref K160309
Regimes: 510(k) Registry: 510(k)CloudTMS Edge for OCD Ref K233742
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3008881376
- Address
- 5 Flossmore Rd, E Falmouth, MA, 02536
Frequently asked questions
How many devices does Teleemg, LLC have in the registry?
The registry currently lists 7 devices for Teleemg, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Teleemg, LLC's devices?
Among its 7 most recently registered devices, Teleemg, LLC has devices listed in FDA 510(k) (7 devices).
What risk classes do Teleemg, LLC's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Teleemg, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Teleemg, LLC in the registry?
The most recently registered devices listed for Teleemg, LLC include FOCUS EMG DEVICE, Neurosoft TMS (also CloudTMS), CloudTMS for OCD and CloudTMS Edge.