The following data is part of a premarket notification filed by Stand Aid Of Iowa, Inc. with the FDA for Roll Aid.
| Device ID | K970164 |
| 510k Number | K970164 |
| Device Name: | ROLL AID |
| Classification | Wheelchair, Powered |
| Applicant | STAND AID OF IOWA, INC. 1009 2ND AVE. Sheldon, IA 51201 |
| Contact | Mike Kleinwolterink |
| Correspondent | Mike Kleinwolterink STAND AID OF IOWA, INC. 1009 2ND AVE. Sheldon, IA 51201 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-16 |
| Decision Date | 1997-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ROLL AID 85719085 not registered Dead/Abandoned |
Thuban, Inc. 2012-09-02 |