FDA Registration
Active
🇺🇸 United States
IMEX, LLC
Reg #: 3030151584
·
FEI: 3030151584
·
Expires 2026
Products
10
Proprietary Names
16
Establishment Types
2
Classifications
10
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Registration Details
- Registration Name
- IMEX, LLC
- Registration Number
- 3030151584
- FEI Number
- 3030151584
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11820 West Market Place, Suite K
- City
- Fulton
- State
- MD
- ZIP
- 20759
- Country
- US
Regulatory Submissions
- 510(k) Number
- K982635
Owner / Operator
- Firm Name
- Imex, LLC
- Operator Number
- 10089504
- Address
- 11820 West Market Place, Suite K
- City
- Fulton
- State
- MD
- Postal Code
- 20759
- Country
- US
- Correspondent
- Bob Patterson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2026-05-06 |
| Monitor, Ultrasonic, Nonfetal | JAF | Class 2 | Radiology | No | 2023-12-13 |
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2023-12-13 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-05-06 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2026-05-06 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2026-05-06 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2026-05-06 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2026-05-06 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2026-05-06 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2026-05-06 |
Proprietary Names
Dynatronics Body Ice Cold Pack
Elite 200
Elite 100R
Elite 200R
Elite 100
Pocket Dop II
Dynatron Tri-Wave Light Probe DCP3
Dynatron Tri-Wave Light Pad DLP3
Dynatron ThermoStim TM Probe DTSP1
Dynatron 125B
CT+
Dynatron Plus 925
Dynatron Solaris Plus 709
Dynatron Solaris Plus 706
Dynatron Solaris Plus Ultrasound Probe WSH05
Dynatron Plus 625
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device