FDA Registration
Active
🇺🇸 United States
TELEEMG, LLC
Reg #: 3008881376
·
FEI: 3008881376
·
Expires 2026
Products
9
Proprietary Names
11
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- TELEEMG, LLC
- Registration Number
- 3008881376
- FEI Number
- 3008881376
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5 Flossmore Rd
- City
- E Falmouth
- State
- MA
- ZIP
- 02536
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133995
Owner / Operator
- Firm Name
- TeleEMG, LLC
- Operator Number
- 10035741
- Address
- 7304 Beverly Blvd #357
- City
- Los Angeles
- State
- CA
- Postal Code
- 90036
- Country
- US
- Correspondent
- Joe F Jabre
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2019-07-29 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2019-07-29 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2019-07-29 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2015-12-10 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2015-12-10 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2015-09-21 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2015-09-21 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2015-12-10 |
| Transcranial Magnetic Stimulator | OBP | Class 2 | Neurology | No | 2016-12-28 |
Proprietary Names
Neuron-Spectrum-4/P with Neuron-Spectrum.NET software
CloudEEG
Neuro-Audio
Focus EMG
CloudEMG
CloudEKG
FocusTMS
Neurosoft TMS
CloudTMS
Cloud TMS
Focus TMS
Establishment Types
Complaint File Establishment per 21 CFR 820.198