Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005210579

FEI Number

3005210579

Entity Name

Jabil Circuit (Shanghai) Ltd.

City/State/Country

Shanghai, CN

Establishment Address

600 Tian Lin Road, Shanghai 200233, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jabil Inc. (Owner Number: 9074019)

Owner / Operator Contact Address

10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nucleus® HybridTM Cochlear Implant System Recharger Kit Activa Recharger Kit Altaviva Clinician Kit Altaviva System Recharger Belt Recharger Drape GentleLase Pro-U Communicator Patient Trial Belt InterStim MicroSystem InterStim MicroSystem Stryker F1 Charger Module Picoway Laser System Nucleus® 24 Cochlear Implant System Leva ® Pelvic Health System Leva Pelvic Digital Health System Leva Pelvic Health System Leva System Cochlear Osia 2 Sound Processor Kit LATITUDE Wave Communicator Model 6280 LATITUDE Wave Communicator Model 6290 Nucleus® Auditory Brainstem Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGQ	Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	Unknown	Class 3	N/A	2018-05-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-01-07
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2021-01-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-01-07
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2021-01-07
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2020-06-30
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2020-06-30
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2020-06-30
MBX	Stimulator, Thalamic, Epilepsy, Implanted	Unknown	Class 3	N/A	2020-06-30
SGS	Deep Brain Stimulation For The Treatment Of Dystonia	Unknown	Class 3	N/A	2020-06-30
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2020-06-30
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2020-06-30
QPT	Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence	Unknown	Class 3	N/A	2025-09-19
OAG	Garment, Storage, Peritoneal Dialysis Catheter	Physical Medicine	Class 1	890.5050	2020-07-13
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2017-11-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2017-11-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-06-12
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2017-12-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-07-02
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2021-02-10
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2020-06-19
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	Gastroenterology, Urology	Class 3	876.5270	2020-08-07
EZW	Stimulator, Electrical, Implantable, For Incontinence	Gastroenterology, Urology	Class 3	876.5270	2020-08-07
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-08-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-12-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-03-10
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2018-05-23
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2024-04-09
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2020-12-18
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2011-10-24
MHE	Implant, Auditory Brainstem	Unknown	Class 3	N/A	2018-05-23

Official Correspondent

No official correspondent registered.

US Agent Details

Lex Pearce Business: JABIL - NYPRO HEALTHCARE DIVISION Email: lex_pearce@jabil.com Phone: (505) 2030277

Related Public Records

Same Entity

Jabil 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
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
3011246727	Jabil Circuit Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3003512059	NYPRO DR, LLC (Bldg 11)	Haina San Cristobal, DO
3004730544	NYPRO DR, LLC (Building 52)	Haina San Cristobal, DO
1424235	Nypro Inc. (Chicago)	GURNEE, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26
K052355	U-Systems, Inc.	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	2005-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005210579. Last updated year: 2026. Please use registration number 3005210579 when referencing this establishment in official correspondence.