The following data is part of a premarket notification filed by Orthion Corp. with the FDA for Shower Stool W/handles.
| Device ID | K823154 |
| 510k Number | K823154 |
| Device Name: | SHOWER STOOL W/HANDLES |
| Classification | Aid, Transfer |
| Applicant | ORTHION CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IKX |
| CFR Regulation Number | 890.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-20 |
| Decision Date | 1982-11-05 |