Data / Medical devices / Hong Kong / Tens Plus Industrial Co.
Tens Plus Industrial Co.: FDA-registered device maker in Hong Kong, Hong Kong, 5 510(k) clearances
Tens Plus Industrial Co. is registered with the FDA (registration 3003836669) in Hong Kong, Hong Kong. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003836669
- Address
- 3/F., C12, Wing Hing Ind. BLDG. 14, Hing Yip ST. Kwun Tong, Kowloon, Hong Kong, Hong Kong, NONE
- Owner or operator
- TENS PLUS INDUSTRIAL CO. (9049984)
- Roles
- Manufacturer
- First device listed
- January 20, 2011
- Registered through
- 2026
- Brand names listed
- AWQ-104L, AWQ-104LT, Axus Es-5 Electro-Acupuncture Device, E-Stim II, E-Stim III, POINTER EXCEL, POINTER EXCEL II, POINTER EXCEL II-LT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Locator, Acupuncture Point | BWJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electro-Acupuncture | BWK | U | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | 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 |
|---|---|---|---|---|---|---|
| February 3, 2021 | K200636 | AXUS ES-5 Electro-Acupuncture Device | BWK | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| June 19, 2006 | K060517 | POINTER EXCEL | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| June 19, 2006 | K060508 | POINTER PLUS | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| April 6, 2006 | K050989 | AWQ-104 | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
| September 6, 2005 | K050435 | E-STIM II | GZJ | Substantially Equivalent | Lhasa Oms, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Electro-Acupuncture
- All makers of Locator, Acupuncture Point
Updated February 3, 2021. 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.