FDA Registration
Active
🇺🇸 United States
PRO-TECH Design & Mfg, Inc.
Reg #: 3013023969
·
FEI: 3013023969
·
Expires 2026
Products
13
Proprietary Names
4
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- PRO-TECH Design & Mfg, Inc.
- Registration Number
- 3013023969
- FEI Number
- 3013023969
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13719 Borate St
- City
- Santa Fe Springs
- State
- CA
- ZIP
- 90670
- Country
- US
Owner / Operator
- Firm Name
- PRO-TECH Design & Mfg, Inc.
- Operator Number
- 9048910
- Address
- 14561 MARQUARDT AVE., --
- City
- Santa Fe Springs
- State
- CA
- Postal Code
- 90670
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Garment, Storage, Peritoneal Dialysis Catheter | OAG | Class 1 | Physical Medicine | No | 2016-04-25 |
| Knife, Intraocular Pressure Lowering | QUQ | Class 2 | General, Plastic Surgery | No | 2024-07-08 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2016-06-28 |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | Class 2 | Neurology | No | 2021-04-14 |
| Prosthesis, Wrist, Hemi-, Ulnar | KXE | Class 2 | Orthopedic | No | 2022-01-27 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2023-12-13 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2023-12-13 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2023-12-13 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-07-24 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2017-07-24 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2021-04-14 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2018-03-12 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2023-12-13 |
Proprietary Names
AbbVie Chest Pack, AbbVie Cross Body Pack, AbbVie Hip Pack, AbbVie Lightweight Vest, AbbVie Snug Vest
Abbvie Fitted Vests and Belts
Xenoscope
EPG Pouch with Adhesive
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)