Medical Toilet Seat
FDA 510(k) K852049 · Pedro Aleman
510(k) numberK852049
Submission
- Device name
- Medical Toilet Seat
- Applicant
- Pedro Aleman
D.F. Mexico, MX - Received
- May 8, 1985
- Decision date
- June 24, 1985
- 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 |
|---|---|---|---|
| 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 |
| K823155 | Lavatory Seat HeightenerILS · Traditional | Orthion Corp. | 11/05/1982SE |
Questions and answers
When was Medical Toilet Seat cleared by the FDA?
Medical Toilet Seat (K852049) received a 510(k) decision of Substantially Equivalent on June 24, 1985, 47 days after the submission was received.
What is the product code of K852049?
The FDA product code is ILS – Adaptor, Hygiene, a Class I (low risk) device regulated under 21 CFR 890.5050.