Data / Medical devices / United States / Hi-Dow International Inc.
Hi-Dow International Inc.: FDA-registered device maker in Maryland Heights, MO, United States, 9 510(k) clearances
Hi-Dow International Inc. is registered with the FDA (registration 3003895865) in Maryland Heights, MO, United States. It lists 15 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 19, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003895865
- Address
- 2555 Metro Blvd, Maryland Heights, MO, United States, 63043
- Owner or operator
- Hi-Dow International Incorporated (9052765)
- Roles
- Complaint file establishment
- First device listed
- August 29, 2002
- Registered through
- 2027
- Brand names listed
- Disposable Face Mask, Disposable Medical Mask, ECHO Massager, Electric Massager, Face Mask, Hidow TENS/EMS, Hidow/Epic Health N95 Surgical Face Mask, LED therapeutic torch and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| January 19, 2024 | K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | NUH | Substantially Equivalent | Hi-Dow International, Inc. | accessdata.fda.gov |
| August 7, 2018 | K181234 | Self-adhesive Electrode | GXY | Substantially Equivalent | Dong Guan OU Kang Electronics Co., Ltd. | accessdata.fda.gov |
| January 17, 2017 | K162663 | WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A | GZJ | Substantially Equivalent | Well-Life Healthcare Limited | accessdata.fda.gov |
| October 9, 2015 | K151693 | Dr-Ho's Foot Pad Electrode | GXY | Substantially Equivalent | Drtv Asia, Ltd. | accessdata.fda.gov |
| November 14, 2014 | K141076 | GARMENT ELECTRODES | GXY | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. | accessdata.fda.gov |
| May 13, 2011 | K102598 | HI-DOW-XP | NUH | Substantially Equivalent | Hi-Dow International, Inc. | accessdata.fda.gov |
| December 19, 2007 | K072168 | OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 | NGX | Substantially Equivalent | Well-Life Healthcare Limited | accessdata.fda.gov |
| September 6, 2007 | K071910 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| February 7, 2007 | K063660 | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 | NUH | Substantially Equivalent | Well-Life Healthcare Limited | accessdata.fda.gov |
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Updated January 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.