The following data is part of a premarket notification filed by The Standing Co., Inc. with the FDA for Powerstand Stand-up Wheelchair.
| Device ID | K032101 |
| 510k Number | K032101 |
| Device Name: | POWERSTAND STAND-UP WHEELCHAIR |
| Classification | Wheelchair, Standup |
| Applicant | THE STANDING CO., INC. 1916 S. NIAGARA ST., SUITE A Saginaw, MI 48602 |
| Contact | Michael A Olvera |
| Correspondent | Michael A Olvera THE STANDING CO., INC. 1916 S. NIAGARA ST., SUITE A Saginaw, MI 48602 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-08 |
| Decision Date | 2004-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B289PS2 | K032101 | 000 |
| B289HPS2 | K032101 | 000 |