FDA Registration
Active
🇺🇸 United States
CLEARLAKE-TECH INC
Reg #: 1721293
·
FEI: 1721293
·
Expires 2026
Products
13
Proprietary Names
2
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- CLEARLAKE-TECH INC
- Registration Number
- 1721293
- FEI Number
- 1721293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 205 Hwy 22 E
- City
- Clear Lake
- State
- SD
- ZIP
- 57226
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223775
Owner / Operator
- Firm Name
- ClearLake-Tech Inc
- Operator Number
- 10093487
- Address
- 205 Hwy 22 E
- City
- Clear Lake
- State
- SD
- Postal Code
- 57226
- Country
- US
- Correspondent
- Amaris Ajamil
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Bone Growth, Non-Invasive | LOF | Class 2 | Orthopedic | No | 2025-05-23 |
| Device, Iontophoresis, Other Uses | EGJ | Class 2 | Physical Medicine | No | 2025-05-23 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2025-05-23 |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | Class 2 | Physical Medicine | No | 2025-05-23 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2025-05-23 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-05-23 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2025-05-23 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2025-05-23 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2025-05-23 |
| Device, Iontophoresis, Specific Uses | KTB | Class 2 | Physical Medicine | No | 2025-05-23 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2025-05-23 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-05-23 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2025-05-23 |
Proprietary Names
Dupel Blue Ionto Electrode
Premium Recovery Electrodes
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only
Manufacture Medical Device