Data / Medical devices / China / Chongqing Rob Linka Science And Technology Co., Ltd.
Chongqing Rob Linka Science And Technology Co., Ltd.: FDA-registered device maker in Chongqing, China, 10 510(k) clearances
Chongqing Rob Linka Science And Technology Co., Ltd. is registered with the FDA (registration 3025367760) in Chongqing, China. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025367760
- Address
- B3-1-2, Liangjiang Health Science and Technology City, No. 2 Yuekang Road Fuxing Street, Liangjiang New Area, Chongqing, China, 400700
- Owner or operator
- Chongqing Rob Linka Science And Technology Co., Ltd. (10086191)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 21, 2022
- Registered through
- 2026
- Brand names listed
- DOMAS, PNrelief, Electric Massager, Electrode cable, Heating Blanket; Heating Belt; Heating Massage Belt, Joint Stimulator; Transcutaneous Electrical Nerve Stimulator Model SM9116, K220150, MSB Consultancy, FloEaze, Massager and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Manual | LYG | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | 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 |
|---|---|---|---|---|---|---|
| July 19, 2024 | K233067 | Wireless TENS & EMS (Model SM9110,SM9113,SM9116) | NUH | Substantially Equivalent | Chongqing Rob Linka Science and Technology Co., Ltd. | accessdata.fda.gov |
| March 13, 2024 | K233070 | Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) | NGX | Substantially Equivalent | Chongqing Rob Linka Science and Technology Co., Ltd. | accessdata.fda.gov |
| February 12, 2024 | K233092 | Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) | NUH | Substantially Equivalent | Chongqing Rob Linka Science and Technology Co., Ltd. | accessdata.fda.gov |
| April 26, 2023 | K230829 | TENS7000 Rechargeable (Model:TENS7000 Rechargeable) | NUH | Substantially Equivalent | Chongqing Rob Linka Science and Technology Co., Ltd. | accessdata.fda.gov |
| May 2, 2022 | K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| February 17, 2022 | K220150 | TENS & PMS (Model: SM9126) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| December 11, 2020 | K201354 | TENS & PMS | NGX | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| December 2, 2019 | K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | NUH | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
| August 26, 2014 | K133979 | TENS | NUH | Substantially Equivalent | Sunmas (H.K.) Trading Limited | accessdata.fda.gov |
| May 10, 2013 | K121719 | SM TENS & PMS | NGX | Substantially Equivalent | Hong Qiangxing (Shenzhen) Electronics Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Pad, Heating, Powered
Updated July 19, 2024. 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.