Data / Medical devices / United States / 21ST Century Scientific, Inc.
21ST Century Scientific, Inc.: FDA-registered device maker in Coeur D Alene, ID, United States, 1 510(k) clearance
21ST Century Scientific, Inc. is registered with the FDA (registration 2027797) in Coeur D Alene, ID, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2027797
- FEI number
- 1000125727
- Address
- 4931 N Manufacturing Way, Coeur D Alene, ID, United States, 83815
- Owner or operator
- 21ST CENTURY SCIENTIFIC, INC. (9000697)
- Roles
- Manufacturer
- First device listed
- July 16, 2021
- Registered through
- 2026
- Brand names listed
- BOUNDER, BOUNDER MANUAL GURNEY, BOUNDER Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stretcher, Wheeled | FPO | 2 | Manufacturer | accessdata.fda.gov |
| Stretcher, Wheeled, Powered | INK | 2 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | 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 |
|---|---|---|---|---|---|---|
| September 3, 2020 | K193599 | BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair | ITI | Substantially Equivalent | 21st Century Scientific, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Powered
- All makers of Stretcher, Wheeled, Powered
- All makers of Stretcher, Wheeled
Updated September 3, 2020. 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.