Lavatory Seat Heightener
FDA 510(k) K823155 · Orthion Corp.
510(k) numberK823155
Submission
- Device name
- Lavatory Seat Heightener
- 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
- ILS – Adaptor, Hygiene
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5050
- Specialty
- Physical Medicine
Other 510(k)s with product code ILS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852049 | Medical Toilet SeatILS · Traditional | Pedro Aleman | 06/24/1985SE |
| K842651 | Commode Chair 98200ILS · Traditional | Guardian Products Co., Inc. | 08/07/1984SE |
| K831547 | Raised Toilet Seats & Nail ClippersILS · Traditional | Fred Sammons, Inc. | 06/08/1983SE |
| K830853 | Lavatory Seat HeightenerILS · Traditional | Lic-Orthion | 06/08/1983SE |
| K830425 | Toilet Seat RaisedILS · Traditional | Maddak, Inc. | 05/09/1983SE |
| K830852 | Shower Stool W/HandlesILS · Traditional | Lic-Orthion | 04/05/1983SE |
| K823641 | Bathing Chair for ChildILS · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823626 | Disposable Tooth BrushILS · Traditional | Fred Sammons, Inc. | 12/30/1982SE |
| K823606 | Plastic Break Resistant MirrorILS · Traditional | Fred Sammons, Inc. | 12/28/1982SE |
| K823156 | Collapsable Lavatory HeightenerILS · Traditional | Orthion Corp. | 11/05/1982SE |
More from Orthion Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K832546 | Mark V High Voltage Galvanic StimulatorrIPF · Traditional | 10/14/1983SE |
| K823156 | Collapsable Lavatory HeightenerILS · Traditional | 11/05/1982SE |
| K823154 | Shower Stool W/HandlesIKX · 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 Lavatory Seat Heightener cleared by the FDA?
Lavatory Seat Heightener (K823155) 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 K823155?
The FDA product code is ILS – Adaptor, Hygiene, a Class I (low risk) device regulated under 21 CFR 890.5050.