The following data is part of a premarket notification filed by Prime Engineering with the FDA for Granstand.
| Device ID | K911608 |
| 510k Number | K911608 |
| Device Name: | GRANSTAND |
| Classification | Wheelchair, Standup |
| Applicant | PRIME ENGINEERING 4838 W. JACQUELYN, SUITE 105 Fresno, CA 93722 |
| Contact | Wilson Boegel |
| Correspondent | Wilson Boegel PRIME ENGINEERING 4838 W. JACQUELYN, SUITE 105 Fresno, CA 93722 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-10 |
| Decision Date | 1991-04-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GRANSTAND 74040046 1625847 Dead/Cancelled |
Axiom Industries, Inc. 1990-03-19 |