Data / Medical devices / Japan / Sunwa Ltd.
Sunwa Ltd.: FDA-registered device maker in Sayama Saitama, Japan, 3 510(k) clearances
Sunwa Ltd. is registered with the FDA (registration 3007736973) in Sayama Saitama, Japan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 7, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007736973
- Address
- 571, Negishi, Sayama Saitama, Japan, 3501325
- Owner or operator
- Sunwa Ltd. / Misawa (10029001)
- Roles
- Manufacturer
- First device listed
- March 27, 2009
- Registered through
- 2026
- Brand names listed
- Evacu-Trac, Power Evacu-Trac, Stair Porter, Stair- Trac, Super-Trac
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Adjustable, Mechanical | INN | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Wheelchair, Portable | ING | 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 |
|---|---|---|---|---|---|---|
| January 7, 2004 | K033469 | GENESIS VERTICAL PLATFORM LIFT | ING | Substantially Equivalent | Garaventa Accessibility | accessdata.fda.gov |
| April 4, 2002 | K020933 | GARAVENTA SUPER-TRAC TRE-52 | ING | Substantially Equivalent | Garaventa Accessibility | accessdata.fda.gov |
| July 1, 1998 | K981486 | STAIR-LIFT | ING | Substantially Equivalent | Garaventa (Canada) , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 7, 2004. 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.