Globalcare Medical Technology Co., Ltd
Zhongshan City Guangdong, CN
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD appears in FDA device records in Zhongshan City Guangdong, CN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Globalcare Medical Technology Co., Ltd between 2020 and 2026. The busiest year on record is 2020, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 2 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253896 | TENS/EMS device (GUSE01) | NUH | Substantially Equivalent | |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | DXN | Substantially Equivalent | |
| K222160 | GUS610 Blood pressure monitor | DXN | Substantially Equivalent | |
| K192633 | GUS831 Compressor Nebulizer | CAF | Substantially Equivalent | |
| K192609 | Globalcare Blood Pressure Monitor | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010880718 | 3010880718 | GLOBALCARE MEDICAL TECHNOLOGY CO., LTD | 7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Zhongshan City Guangdong 528415 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXQBlood Pressure Cuff
- ILYLamp, Infrared, Therapeutic Heating
- OCRLung Sound Monitor
- BYGMask, Oxygen
- CAFNebulizer (Direct Patient Interface)
- HGXPump, Breast, Powered
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain