Data / Medical devices / China / Suzhou Minhua Medical Equipment Co.,Ltd.
Suzhou Minhua Medical Equipment Co.,Ltd.: FDA-registered device maker in SuZhou Jiangsu, China, 5 510(k) clearances
Suzhou Minhua Medical Equipment Co.,Ltd. is registered with the FDA (registration 3011529836) in SuZhou Jiangsu, China. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 15, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011529836
- Address
- No. 789 Wufang Road YouYi Industrial Park, SuZhou Jiangsu, China, 215222
- Owner or operator
- Suzhou Minhua Medical Equipment Co.,Ltd. (10048668)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- February 10, 2015
- Registered through
- 2027
- Brand names listed
- CONNECTOR,ADAPTER, ICEFLOW Cold Therapy System, Lympha Press Leg 4, Medline Hemo-Force DVT Compression Sleeve, Medline Reusable Blood Pressure Cuff, Medline Singe Patient Use Blood Pressure Cuff, NBP Cuff for Adult; NBP Cuff for Child; NBP Cuff for Infant; NBP Cuff for Neonates; NBP extension hose /adapter, Reusable Blood Pressure Cuff Over-The-Counter Use and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Contract manufacturer | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Manufacturer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Contract manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Contract manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| January 15, 2025 | K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | JOW | Substantially Equivalent | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | accessdata.fda.gov |
| December 21, 2023 | K233276 | Reusable Blood Pressure Cuff | DXQ | Substantially Equivalent | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | accessdata.fda.gov |
| June 29, 2018 | K180389 | Venera 508 Deep Vein Thrombosis (DVT) Prevention System | JOW | Substantially Equivalent | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | accessdata.fda.gov |
| December 19, 2017 | K171889 | Reusable Blood Pressure Cuff | DXQ | Substantially Equivalent | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | accessdata.fda.gov |
| May 15, 2015 | K143728 | Minhua Disposable Blood Pressure Cuff | DXQ | Substantially Equivalent | Suzhou Minhua Medical Apparatus | accessdata.fda.gov |
Compare with other makers
- All makers of Sleeve, Limb, Compressible
- All makers of Blood Pressure Cuff
- All makers of Mattress, Flotation Therapy, Non-Powered
- All makers of Protector, Skin Pressure
- All makers of Cushion, Wheelchair
- All makers of Cushion, Flotation
Updated January 15, 2025. 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.