Data / Medical devices / China / Jabil Circuit (Shanghai) Ltd.
Jabil Circuit (Shanghai) Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Jabil Circuit (Shanghai) Ltd. is registered with the FDA (registration 3005210579) in Shanghai, China. It lists 30 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 14, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005210579
- Address
- 600 Tian Lin Road, Shanghai, China, 200233
- Owner or operator
- Jabil Inc. (9074019)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- October 24, 2011
- Registered through
- 2027
- Brand names listed
- Activa, Altaviva Clinician Kit, Altaviva System, C320LBB Delivery System, Cochlear Osia 2 Sound Processor Kit, Communicator, GentleLase Pro-U, GentleMax Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Active Implantable Bone Conduction Hearing System | PFO | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Contract manufacturer | accessdata.fda.gov |
| Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | PGQ | 3 | Contract manufacturer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Contract manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Contract manufacturer | accessdata.fda.gov |
| Counter, Sponge, Surgical | LWH | 1 | Contract manufacturer | accessdata.fda.gov |
| Deep Brain Stimulation For The Treatment Of Dystonia | SGS | 3 | Contract manufacturer | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Garment, Storage, Peritoneal Dialysis Catheter | OAG | 1 | Contract manufacturer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Contract manufacturer | accessdata.fda.gov |
| Implant, Auditory Brainstem | MHE | 3 | Contract manufacturer | accessdata.fda.gov |
| Implant, Cochlear | MCM | 3 | Contract manufacturer | accessdata.fda.gov |
| Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | QON | 3 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Contract manufacturer | accessdata.fda.gov |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Contract manufacturer | accessdata.fda.gov |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | 3 | Contract manufacturer | accessdata.fda.gov |
| Perineometer | HIR | 2 | Contract manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Implantable, For Incontinence | EZW | 3 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | 3 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | 3 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | 3 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | 3 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | 3 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Thalamic, Epilepsy, Implanted | MBX | 3 | Contract manufacturer | accessdata.fda.gov |
| Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence | QPT | 3 | Contract manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Contract manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Contract manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| August 14, 2015 | K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electrical, Implanted, For Essential Tremor
- All makers of Stimulator, Thalamic, Epilepsy, Implanted
- All makers of Deep Brain Stimulation For The Treatment Of Dystonia
- All makers of Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- All makers of Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
- All makers of Implant, Cochlear
Updated August 14, 2015. 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.