Data / Medical devices / China / Wuxi Jiajian Medical Instrument Co., Ltd
Wuxi Jiajian Medical Instrument Co., Ltd: FDA-registered device maker in Wuxi Jiangsu, China, 12 510(k) clearances
Wuxi Jiajian Medical Instrument Co., Ltd is registered with the FDA (registration 3007710601) in Wuxi Jiangsu, China. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007710601
- Address
- No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi Jiangsu, China, 214116
- Owner or operator
- Wuxi Jiajian Medical Instrument Co., Ltd (10029771)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- June 24, 2009
- Registered through
- 2026
- Brand names listed
- Dry Needles, Infrared Heating Device, PM-750, Jiajian Self-adhesive Electrode, Jiajian® Acupuncture Needle, Jiajian® CMN Stimulator, Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 & WQ-6F, Jiajian® Pointoselect Digital, Jiajian® Self-adhesive Electrode and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Electro-Acupuncture | BWK | U | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 28, 2025 | K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | BWK | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| March 27, 2024 | K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | NUH | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| January 24, 2023 | K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) | GZJ | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 27, 2021 | K202861 | Needle Stimulator | BWK | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| June 18, 2021 | K202893 | Transcutaneous Electrical Nerve Stimulator | GZJ | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| February 3, 2021 | K192568 | Jiajian Self-Adhesive Electrode | GXY | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 28, 2013 | K123958 | JIAJIAN POINTOSELECT DIGITAL | GZJ | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 16, 2013 | K130768 | JIAJIAN CMN STIMULATOR | BWK | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| April 11, 2013 | K122812 | JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS | BWK | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| May 2, 2012 | K112288 | JIAJIAN TENS | GZJ | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 11, 2009 | K090199 | JIAJIAN ACUPUNCTURE NEEDLE | MQX | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
| June 23, 2009 | K090198 | JIAJIAN SELF-ADHESIVE ELECTRODE | GXY | Substantially Equivalent | Wuxi Jiajian Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Electro-Acupuncture
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Needle, Acupuncture, Single Use
- All makers of Lamp, Infrared, Therapeutic Heating
Updated March 28, 2025. 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.