Data / Medical devices / United States / Chek Medical
Chek Medical: FDA-registered device maker in Aurora, CO, United States, 1 510(k) clearance
Chek Medical is registered with the FDA (registration 3029939996) in Aurora, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 25, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029939996
- Address
- 25489 E Fair Dr, Aurora, CO, United States, 80016
- Owner or operator
- CHEK Medical (10089240)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 25, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Repackager or relabeler, Specification developer | 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 25, 2021 | K200177 | Low-frequency Multi-function physiotherapy instrument | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
Updated March 25, 2021. 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.