Data / Medical devices / United States / Design Specific Us Inc
Design Specific Us Inc: FDA-registered device maker in Wilmington, DE, United States, 1 510(k) clearance
Design Specific Us Inc is registered with the FDA (registration 3008457024) in Wilmington, DE, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 23, 2010. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008457024
- Address
- 501 Silverside Rd Ste Silverside Road, Wilmington, DE, United States, 19809
- Owner or operator
- Design Specific US Inc (10039396)
- Roles
- Specification developer
- First device listed
- June 28, 2012
- Registered through
- 2027
- Brand names listed
- 'Comfort' Transport and Treatment Chair, Bariatric Treatment Chair, Compact Wheelchair Platform
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Examination And Treatment | FRK | 1 | Specification developer | accessdata.fda.gov |
| Chair, Positioning, Electric | INO | 2 | Specification developer | accessdata.fda.gov |
| Device, Patient Transfer, Powered | FRZ | 2 | 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 |
|---|---|---|---|---|---|---|
| December 23, 2010 | K101723 | COMPACT WHEELCHAIR PLATFORM | INO | Substantially Equivalent | Design Specific Fletcher | accessdata.fda.gov |
Compare with other makers
- All makers of Chair, Positioning, Electric
- All makers of Chair, Examination And Treatment
- All makers of Device, Patient Transfer, Powered
Updated December 23, 2010. 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.