Data / Medical devices / Canada / Cloud DX Inc.
Cloud DX Inc.: FDA-registered device maker in Kitchener Ontario, Canada, 2 510(k) clearances
Cloud DX Inc. is registered with the FDA (registration 3010984687) in Kitchener Ontario, Canada. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 14, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010984687
- Address
- 100 - 72 Victoria Street S, Kitchener Ontario, Canada, N2G 4Y9
- Owner or operator
- CloudDX Inc. (10048345)
- Roles
- Repackager or relabeler
- First device listed
- August 26, 2016
- Registered through
- 2026
- Brand names listed
- Cloud DX JPD-FR412 Dual Mode Thermometer (Forehead and Ear), Cloud DX Wireless Oximeter WPO-10B, Cloud DX Wireless Weight Scale WWS-10
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 14, 2018 | K172795 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| November 3, 2017 | K170965 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Scale, Stand-On, Patient
- All makers of Continuous Measurement Thermometer
Updated March 14, 2018. 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.