The following data is part of a premarket notification filed by Lic-orthion with the FDA for Shower Stool W/handles.
| Device ID | K830852 |
| 510k Number | K830852 |
| Device Name: | SHOWER STOOL W/HANDLES |
| Classification | Adaptor, Hygiene |
| Applicant | LIC-ORTHION 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ILS |
| CFR Regulation Number | 890.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-17 |
| Decision Date | 1983-04-05 |