Data / Medical devices / China / Dongguan Bohuikang Technology Co.,ltd
Dongguan Bohuikang Technology Co.,ltd: FDA-registered device maker in Dongguan Guangdong, China, 2 510(k) clearances
Dongguan Bohuikang Technology Co.,ltd is registered with the FDA (registration 3023330992) in Dongguan Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3023330992
- Address
- 5th Floor,No 5, Second Street,Huaide Shui Xiang New Strict, Humen town, Dongguan Guangdong, China, 523165
- Owner or operator
- Dongguan Bohuikang Technology Co.,Ltd (10085234)
- Roles
- Manufacturer
- First device listed
- May 23, 2022
- Registered through
- 2026
- Brand names listed
- GLOBALCARE MICRO 11 AND MICROCARE(TENS), KR-600, KR-800,KR-280, KR-300, TENS&EMS: KRES100D, KRES1010,KRES1020,KRES1080,KRES100B,AST1009,AST100B, KRES2080, 9029
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 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 |
|---|---|---|---|---|---|---|
| May 6, 2022 | K213788 | TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) | NUH | Substantially Equivalent | Dongguan Bohuikang Technology Co.,Ltd | accessdata.fda.gov |
| May 6, 1991 | K903394 | GLOBALCARE MICRO 11 AND MICROCARE (TENS) | GZJ | Substantially Equivalent | Globalcare Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
Updated May 6, 2022. 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.