Shower Stool W/Handles
FDA 510(k) K823154 · Orthion Corp.
510(k) numberK823154
Submission
- Device name
- Shower Stool W/Handles
- Applicant
- Orthion Corp.
Mchenry, IL, US - Received
- October 20, 1982
- Decision date
- November 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKX – Aid, Transfer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5050
- Specialty
- Physical Medicine
Other 510(k)s with product code IKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K862895 | TricyclesIKX · Traditional | Mednet, Inc. | 08/13/1986SE |
| K842650 | Wall Grab Bars 98130-98136IKX · Traditional | Guardian Products Co., Inc. | 08/10/1984SE |
| K831541 | Tub Transfer Bench BK6481IKX · Traditional | Fred Sammons, Inc. | 06/02/1983SE |
| K823640 | Bath Tub Safety BarIKX · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823639 | Board to Transfer Paralyzed Patient FromIKX · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823634 | Chair or Bed Leg ExtendersIKX · Traditional | Fred Sammons, Inc. | 12/28/1982SE |
| K823153 | Bath Tub Seat & Bath BoardIKX · Traditional | Orthion Corp. | 11/05/1982SE |
| K821903 | Disc-O-AidIKX · Traditional | M. Dahm International Aps | 07/20/1982SE |
| K821010 | Bathtub Transfer BenchIKX · Traditional | Guardian Products Co., Inc. | 04/21/1982SE |
| K813629 | BK-6111 Hi-D Transfer BoardIKX · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K832546 | Mark V High Voltage Galvanic StimulatorrIPF · Traditional | 10/14/1983SE |
| K823156 | Collapsable Lavatory HeightenerILS · Traditional | 11/05/1982SE |
| K823155 | Lavatory Seat HeightenerILS · Traditional | 11/05/1982SE |
| K823153 | Bath Tub Seat & Bath BoardIKX · Traditional | 11/05/1982SE |
| K823152 | Ob Help ArmILE · Traditional | 11/05/1982SE |
| K823151 | Ob Tripp Transport ChairINM · Traditional | 11/05/1982SE |
| K823150 | Sesam Treatment TableINQ · Traditional | 11/05/1982SE |
| K823149 | Ob Tilt TableINW · Traditional | 11/05/1982SE |
| K823105 | Resi-WalkerITJ · Traditional | 11/05/1982SE |
| K812701 | Ortho-Therm Infrared SensorIYM · Traditional | 10/13/1981SE |
Questions and answers
When was Shower Stool W/Handles cleared by the FDA?
Shower Stool W/Handles (K823154) received a 510(k) decision of Substantially Equivalent on November 5, 1982, 16 days after the submission was received.
What is the product code of K823154?
The FDA product code is IKX – Aid, Transfer, a Class I (low risk) device regulated under 21 CFR 890.5050.