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Data / Medical devices / China / Jabil Circuit (Shanghai) Ltd.

Jabil Circuit (Shanghai) Ltd.: FDA-registered device maker in Shanghai, China, 8 510(k) clearances and 7 PMA approvals

Jabil Circuit (Shanghai) Ltd. is registered with the FDA (registration 3010972758) in Shanghai, China. It lists 19 device types. The FDA files 8 510(k) clearances and 7 PMA approvals under its listings, the newest dated September 18, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3010972758
Address
6671 Jinhai Highway, Shanghai, China, 200000
Owner or operator
Jabil Inc. (9074019)
Roles
Exporter to the US
First device listed
October 24, 2011
Registered through
2026
Brand names listed
Activa, Altaviva Clinician Kit, Altaviva System, Communicator, GentleLase Pro-U, GentleMax Pro, InterStim MicroSystem, LATITUDE Wave Communicator Model 6280 and more

Devices it lists

DeviceProduct codeClassRoleSource
Deep Brain Stimulation For The Treatment Of DystoniaSGS3Exporter to the USaccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Exporter to the USaccessdata.fda.gov
Garment, Storage, Peritoneal Dialysis CatheterOAG1Exporter to the USaccessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific ConnectorsPIF2Exporter to the USaccessdata.fda.gov
Implanted Electrical Device Intended For Treatment Of Fecal IncontinenceQON3Exporter to the USaccessdata.fda.gov
Lasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisPDZ2Exporter to the USaccessdata.fda.gov
Medical Device Data SystemOUG1Exporter to the USaccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Exporter to the USaccessdata.fda.gov
PerineometerHIR2Exporter to the USaccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Exporter to the USaccessdata.fda.gov
Stimulator, Electrical, Implantable, For IncontinenceEZW3Exporter to the USaccessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential TremorPJS3Exporter to the USaccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian SymptomsNHL3Exporter to the USaccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY3Exporter to the USaccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Exporter to the USaccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyQRB3Exporter to the USaccessdata.fda.gov
Stimulator, Thalamic, Epilepsy, ImplantedMBX3Exporter to the USaccessdata.fda.gov
Stimulator, Tibial, Electrical, Implantable, For Urinary IncontinenceQPT3Exporter to the USaccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 13, 2022K220853PicoWay Laser SystemGEXSubstantially EquivalentCandela Corporationaccessdata.fda.gov
June 30, 2022K213913leva Pelvic Health SystemHIRSubstantially EquivalentRenovia, Inc.accessdata.fda.gov
May 26, 2020K201111GentleMax Pro PlusGEXSubstantially EquivalentCandela Corporationaccessdata.fda.gov
May 16, 2017K163002Kangaroo Feeding Tube with IRIS TechnologyKNTSubstantially EquivalentCovidien (Dba Medtronic)accessdata.fda.gov
August 14, 2015K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleERLSubstantially EquivalentMedtronic Xomed, Inc.accessdata.fda.gov
November 7, 2014K140732CANDELA GENTLELASE FAMILY OF LASER SYSTEMSGEXSubstantially EquivalentCandela Corp.accessdata.fda.gov
May 9, 2014K140122CANDELA GENTLEMAX FAMILY OF LASER SYSTEMGEXSubstantially EquivalentCandela Corp.accessdata.fda.gov
October 30, 2003K033172CANDELA GENTLEYAG FAMILY OF LASER SYSTEMSGEXSubstantially EquivalentCandela Corp.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
September 18, 2025P240011Medtronic Altaviva SystemQPT15September 14, 2026accessdata.fda.gov
March 14, 2011P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMQON349October 9, 2026accessdata.fda.gov
April 27, 2004P030017PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMLGW373September 22, 2026accessdata.fda.gov
September 29, 1997P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW448October 9, 2026accessdata.fda.gov
July 31, 1997P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY528October 6, 2026accessdata.fda.gov
June 17, 1994P910077VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATORLWS184July 1, 2026accessdata.fda.gov
November 30, 1984P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW612October 6, 2026accessdata.fda.gov

Compare with other makers

Updated September 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.