The following data is part of a premarket notification filed by Stoneheart, Inc. with the FDA for Stoneheart Roller Aid.
| Device ID | K925247 |
| 510k Number | K925247 |
| Device Name: | STONEHEART ROLLER AID |
| Classification | Chair, With Casters |
| Applicant | STONEHEART, INC. 224 2ND STREET, BOX 329 Cheney, WA 99004 |
| Contact | Heather Stone |
| Correspondent | Heather Stone STONEHEART, INC. 224 2ND STREET, BOX 329 Cheney, WA 99004 |
| Product Code | INM |
| CFR Regulation Number | 890.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-16 |
| Decision Date | 1993-02-12 |