Wuxi Jiajian Medical Instrument Co., Ltd.
Manufacturer and brand owner in Wuxi, Jiangsu, China. 6 device types, 10 products catalogued, 12 clearances.
Wuxi Jiajian Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Electrode, Cutaneous, Needle, Acupuncture, Single Use and 4 other device types. 9 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
6device types registered with the FDA
10products catalogued under its own name
12510(k) clearances
Registration
| Registered name | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007710601 |
| FEI number | 3007710601 |
| DUNS | 529966489 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 无锡佳健医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 91320200782705450Q |
| Source | NMPA UDI database |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | No. 35 Baiqiao Rd., Ehu Town, Xishan District, |
| Postal code | 214116 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrode, Cutaneous | Class 2 | Jiajian Self-adhesive Electrode, Self-adhesive Electrode, Welllife CM5050, Welllife CM4040, Welllife CM13088, Self-Adhering Electrodes and 1 more | 2009 | 47 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Infrared Heating Device, PM-750 | 2016 | 235 |
| Needle, Acupuncture, Single Use | Class 2 | Seven-stars Needles, Dry Needles, Jiajian® Acupuncture Needle, Ultra Fine Dry Needles, Sterile Acupuncture Needles | 2009 | 33 |
| Stimulator, Electro-Acupuncture | Class U | Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 & WQ-6F, Jiajian® CMN Stimulator, Needle Stimulator (CMNS6-1 PLUS, CMNS6-3), NEEDLE STIMULATOR, Model BD-360, Needle Stimulator, Model CMNS6-1 and CMNS6-2 | 2013 | 2 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Jiajian® TENS, THETA-Stim, Model TS-1000, Transcutaneous Electrical Nerve Stimulator, Transcutaneous Electrical Nerve Stimulator (model TENS WMPS6-1), Jiajian® Pointoselect Digital | 2012 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | 2024 | 57 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| ACE | MQX | 113 |
| Shunli | MQX | 43 |
| Jiajian | MQX | 35 |
| alegriaCare | GXY | 13 |
| Lot Fancy | MQX | 9 |
| Jiajian | GZJ | 6 |
| Jiajian | GXY | 2 |
| Jiajian | NUH | 1 |
| Infrared Heating device | ILY | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K244030 | 2025-03-28 | BWK | Traditional | This company |
| K231425 | 2024-03-27 | NUH | Traditional | This company |
| K222879 | 2023-01-24 | GZJ | Traditional | This company |
| K202861 | 2021-08-27 | BWK | Traditional | This company |
| K202893 | 2021-06-18 | GZJ | Special | This company |
| K192568 | 2021-02-03 | GXY | Special | This company |
| K123958 | 2013-10-28 | GZJ | Traditional | This company |
| K130768 | 2013-08-16 | BWK | Traditional | This company |
| K122812 | 2013-04-11 | BWK | Traditional | This company |
| K112288 | 2012-05-02 | GZJ | Traditional | This company |
| K090199 | 2009-08-11 | MQX | Traditional | This company |
| K090198 | 2009-06-23 | GXY | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Employees | 40 |
| Main products | Acupuncture needles, TCM electronic products, Self-adhesive electrodes |
| Certifications | CE, FDA, Canada CMDC, ISO13485 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.