Data / Medical devices / China / Gaboss International Limited
Gaboss International Limited: FDA-registered device maker in KOWLOON Xinjiang, China, 1 510(k) clearance
Gaboss International Limited is registered with the FDA (registration 3015501220) in KOWLOON Xinjiang, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015501220
- Address
- 19H Maxgrand Plaza No.3 Tai Yau Street San Po Kong, KOWLOON Xinjiang, China, 999077
- Owner or operator
- GABOSS INTERNATIONAL LIMITED (10062777)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 7, 2020
- Registered through
- 2026
- Brand names listed
- Breast Pump, Freestyle Flex Connector, Massage Gun, Silver Nursing Cups, Warming Lactation Massager, Wearable Milk Collector, mask, massage chair and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Nursing Pad, Cohesive Gel | NXH | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 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 |
|---|---|---|---|---|---|---|
| January 13, 2023 | K222782 | Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) | HGX | Substantially Equivalent | Zhejiang Carebao Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Scaler, Periodontic
- All makers of Pad, Heating, Powered
- All makers of Massager, Therapeutic, Electric
- All makers of Accessory, Surgical Apparel
- All makers of Nursing Pad, Cohesive Gel
- All makers of Pack, Hot Or Cold, Water Circulating
Updated January 13, 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.