Data / Medical devices / China / MedHealth Medical Limited
MedHealth Medical Limited: FDA-registered device maker in Shenzhen Guangdong, China, 5 510(k) clearances
MedHealth Medical Limited is registered with the FDA (registration 3010190204) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010190204
- Address
- 701/101, BLDG 24, Block B, Yuanshan Zone, Shangcun, Gongming, Shenzhen Guangdong, China, 518106
- Owner or operator
- Medhealth Medical Limited (10042861)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 7, 2013
- Registered through
- 2026
- Brand names listed
- ALP 1 Calf Garment; ALP 1A Calf Garment, ALP 1SM Calf Garment; ALP 2 Calf Garment; ALP 2XL Garment; ALP 2XXL Calf Garment; ALP 3 Thigh Garment;, ALP 3SM Thigh Garment; ALP 4 Thigh Garment; ALP 4XL Thigh Garment;, CIRCASSIST DVT PROPHYLAXIS SLEEVE, CIRCASSIST DVT PUMP, Calf/Thigh Garment, Cyl.Cuff DPDB(T90410,T90420,T90430,T90440,T90450,T90460,T90470, T90411,T90421,T90431,T90441,T90451,T90461,T90471), Cyl.Cuff DPSB(T90210,T90220,T90230,T90240,T90250,T90260,T90270, T90211,T90221,T90231,T90241,T90251,T90261,T90271) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 1 | 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 |
|---|---|---|---|---|---|---|
| December 14, 2023 | K231801 | MedHealth DVT compression Devices MHH900S/MHH900E | JOW | Substantially Equivalent | Medhealth Medical Limited | accessdata.fda.gov |
| September 19, 2020 | K201532 | B&J DVT Calf/Thigh Garments, Models 801/830 Series | JOW | Substantially Equivalent | B&J Manufacturing , Ltd. | accessdata.fda.gov |
| September 18, 2020 | K201547 | B&J DVT Foot Garments, Models 820 Series | JOW | Substantially Equivalent | B&J Manufacturing , Ltd. | accessdata.fda.gov |
| July 10, 2020 | K200568 | B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System | JOW | Substantially Equivalent | B&J Manufacturing , Ltd. | accessdata.fda.gov |
| July 8, 2020 | K200154 | B&J DVT Compression Devices MHH800/MHH800SQ | JOW | Substantially Equivalent | B&J Manufacturing , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 14, 2023. 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.