FDA Registration
Active
🇺🇸 United States
PREFERRED DEPOT
Reg #: 3013917867
·
FEI: 3013917867
·
Expires 2026
Products
15
Proprietary Names
14
Establishment Types
3
Classifications
15
Registration Details
- Registration Name
- PREFERRED DEPOT
- Registration Number
- 3013917867
- FEI Number
- 3013917867
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 39 Parker
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101510
Owner / Operator
- Firm Name
- Preferred Depot
- Operator Number
- 10060025
- Address
- 39 parker
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Isaac Elkah
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-03-09 |
| Skin Resurfacing Rf Applicator | OUH | Class 2 | General, Plastic Surgery | No | 2019-03-21 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2022-10-25 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2022-10-25 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2022-10-25 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2022-10-25 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2025-09-03 |
| Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | OHV | Class 2 | General, Plastic Surgery | No | 2025-07-14 |
| Massager, Vacuum, Light Induced Heating | NUV | Class 2 | General, Plastic Surgery | No | 2024-06-25 |
| Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | PAY | Class 2 | General, Plastic Surgery | No | 2019-03-21 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2019-03-21 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2019-03-21 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2019-03-21 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-06-25 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2024-11-25 |
Proprietary Names
PathKeeper System
FSR Fractional Skin Resurfacing Applicator
BRH Medical Ltd.
Sofwave
I-Tech Industries
Sofwave Inc.
Newa Over the Counter
EndyGel
Newa Skin Therapy System
Contour
I-Tech Industries SRL
Endymed
EndyMed Pro
Glow Pure
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Remanufacture Medical Device