Data / Medical devices / United States / The Standing Company
The Standing Company: FDA-registered device maker in Saginaw, MI, United States, 2 510(k) clearances
The Standing Company is registered with the FDA (registration 3007494904) in Saginaw, MI, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 22, 2004. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007494904
- Address
- 5848 Dixie Highway, Saginaw, MI, United States, 48601
- Owner or operator
- The Standing Company (10028896)
- Roles
- Manufacturer
- First device listed
- March 17, 2009
- Registered through
- 2026
- Brand names listed
- PS-2 Powerstand Stand-up Wheelchair HPS-2 Half Power Standing Wheelchair, Superstand Stand-up Wheelchair
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wheelchair, Standup | IPL | 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 22, 2004 | K032101 | POWERSTAND STAND-UP WHEELCHAIR | IPL | Substantially Equivalent | The Standing Co., Inc. | accessdata.fda.gov |
| October 2, 1996 | K962278 | SUPERSTAND STAND-UP WHELLCHAIR | IPL | Substantially Equivalent | The Standing Co., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 16, 13 | 67076 | Class II | Terminated | Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external | Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is available at no charge. | accessdata.fda.gov |
Compare with other makers
Updated February 19, 2014. 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.