Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013023969

FEI Number

3013023969

Entity Name

PRO-TECH Design & Mfg, Inc.

City/State/Country

Santa Fe Springs, CA, US

Establishment Address

13719 Borate St, Santa Fe Springs, CA 90670, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRO-TECH Design & Mfg, Inc. (Owner Number: 9048910)

Owner / Operator Contact Address

14561 MARQUARDT AVE., --, Santa Fe Springs, CA 90670, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AbbVie Chest Pack, AbbVie Cross Body Pack, AbbVie Hip Pack, AbbVie Lightweight Vest, AbbVie Snug Vest Abbvie Fitted Vests and Belts Xenoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAG	Garment, Storage, Peritoneal Dialysis Catheter	Physical Medicine	Class 1	890.5050	2016-04-25
QUQ	Knife, Intraocular Pressure Lowering	General, Plastic Surgery	Class 2	878.4400	2024-07-08
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2016-06-28
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2021-04-14
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2022-01-27
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2023-12-13
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2023-12-13
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2023-12-13
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2022-01-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-07-24
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2017-07-24
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2021-04-14
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Orthopedic	Class 2	888.3810	2022-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRO-TECH Design & Mfg, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010531069	PRO-TECH Design & Mfg, Inc.	Arlington, TX, US
2183319	SURGICAL TECHNOLOGIES, INC.	ST. PAUL, MN, US
2032521	PRO-TECH DESIGN & MFG., INC.	SANTA FE SPRINGS, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2018	St. Jude Medical, Inc.	3	Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Z-0459-2026	Abbott Medical	3	Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Z-2265-2024	Abbott Medical	3	Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

Similar Registrations

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2182207	MEDTRONIC NEUROMODULATION	Minneapolis, MN, US
3005210579	Jabil Circuit (Shanghai) Ltd.	Shanghai, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013023969. Last updated year: 2026. Please use registration number 3013023969 when referencing this establishment in official correspondence.