Hong Qiangxing (Shen Zhen) Electronics Limited
Manufacturer and brand owner in Shenzhen, Guangdong, China. 19 device types, 184 products catalogued.
Hong Qiangxing (Shen Zhen) Electronics Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Dermatome, Bandage, Elastic and 17 other device types. 181 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
19device types registered with the FDA
184products catalogued under its own name
Registration
| Registered name | HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010402752 |
| FEI number | 3010402752 |
| DUNS | 421286946 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市宏强兴电子有限公司 |
|---|---|
| Source | provincial manufacturer licence lists |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 2F, Yongcheng Blvd, Xicheng Industrial Zone |
| Postal code | 518126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Elastic | Class 1 | Waist Belt | 2014 | 280 |
| Bottle, Collection, Vacuum | Class 2 | Skincare rejuvenation, SM9003, SM9005, SonicLift | 2020 | 88 |
| Brush, Dermabrasion, Powered | Class 1 | 2018 | 65 | |
| Cable, Electrode | Class 2 | Electrode cable | 2013 | 47 |
| Dermatome | Class 1 | 2018 | 6 | |
| Electrode, Cutaneous | Class 2 | monthlee electrodes, SM Electrodes, Massage gloves, Massage socks, Massage belts, Massage slippers, Proactive Elle TENS replacement electrodes (715-736), Foot mat, VPOD Electrodes | 2019 | 47 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | 2023 | 65 | |
| Light Based Over The Counter Wrinkle Reduction | Class 2 | Face Evolution-EMS & LED Facial Toning Therapy | 2019 | 67 |
| Massager, Therapeutic, Electric | Class 1 | Massager (Pro Series103-104, SM9008-9098, SM9118-9198); Foot Massager; Foot & Calf Massager | 2013 | 437 |
| Massager, Therapeutic, Manual | Class 1 | Manual massager; Massage slippers | 2013 | 113 |
| Massager, Vacuum, Radio Frequency Induced Heat | Class 2 | 2023 | 13 | |
| Over-The-Counter Powered Light Based Laser For Acne | Class 2 | Face Evolution-EMS & LED Facial Toning Therapy | 2019 | 59 |
| Pad, Heating, Powered | Class 2 | Powered heating pad; Heating Kneepad; Heating Vest; Heating Gloves, Heating Jacket; Heating Blanket; Heating Belt; Heating Massage Belt | 2013 | 144 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | Nooro Body & Foot Stimulator (SM9141, SM9142), ManaFlexx 2 (model: MF002-RX, MF002-OTC), Pain Therapy Device (SM9055, SM9075, SM9910, SM9067, SM9587W), Epulse Ultra 1420, SM9075 Neocarbon | 2024 | 22 |
| Stimulator, Muscle, Powered | Class 2 | Nooro Body & Foot Stimulator (SM9141, SM9142), Wireless TENS & EMS (Model SM9110, SM9113, SM9116), Foot Pain Relief, YUNJIAODIDAN Foot Massager 1, CoreeLab ESPF Massager, ManaFlexx 2 (model: MF002-RX, MF002-OTC) and 3 more | 2024 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | PainX® TENS PRO, Model SM9069C, TENS & PMS (Model: SM9126, SM9910), DrBash TENS&EMS, PainX® TENS PRO, SM9069C, Takoo, Nooro Body & Foot Stimulator (SM9141, SM9142) and 54 more | 2013 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Nooro Body & Foot Stimulator (SM9141, SM9142), Wireless TENS & EMS (Model SM9110, SM9113, SM9116), Foot Pain Relief, YUNJIAODIDAN Foot Massager 1, CoreeLab ESPF Massager, ManaFlexx 2 (model: MF002-RX, MF002-OTC) and 3 more | 2024 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | PainX® TENS PRO, Model SM9069C, TENS & PMS (Model: SM9126, SM9910), DrBash TENS&EMS, PainX® TENS PRO, SM9069C, Takoo, Nooro Body & Foot Stimulator (SM9141, SM9142) and 53 more | 2013 | 57 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Class 2 | Face Evolution-EMS & LED Facial Toning Therapy | 2019 | 22 |
Own-Brand Listings
Clearances
No clearance names Hong Qiangxing (Shen Zhen) Electronics Limited as applicant. 12 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253740 | 2025-12-23 | NUH | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K243334 | 2024-11-22 | NUH | Traditional | XF Agencija Limited |
| K233067 | 2024-07-19 | NUH | Traditional | Chongqing ROB Linka Science AND Technology Co., Ltd. |
| K233092 | 2024-02-12 | NUH | Traditional | Chongqing ROB Linka Science AND Technology Co., Ltd. |
| K220283 | 2022-05-02 | NUH | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K220152 | 2022-04-19 | NUH | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K220150 | 2022-02-17 | NUH | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K201354 | 2020-12-11 | NGX | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K190009 | 2019-12-02 | NUH | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K183154 | 2019-03-26 | GXY | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K133108 | 2014-08-05 | NGX | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
| K121719 | 2013-05-10 | NGX | Traditional | Hong Qiangxing (Shenzhen) Electronics Limited |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Employees | 200 |
| Factory area | 5000㎡ |
| Main products | TENS units, EMS muscle stimulators, Skincare beauty devices, Heated massagers, Neurostimulation devices |
| Certifications | FDA 510K, ISO 13485, Medical CE, MDSAP, FCC |
| Export markets | Global, 5000+ clients |
| OEM and ODM | Offered |
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.