Secura Bath Seat
FDA 510(k) K812483 · Maddak, Inc.
510(k) numberK812483
Submission
- Device name
- Secura Bath Seat
- Applicant
- Maddak, Inc.
Mchenry, IL, US - Received
- August 31, 1981
- Decision date
- September 14, 1981
- 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 |
|---|---|---|
| K841700 | Walk & RollINM · Traditional | 05/11/1984SE |
| K841698 | Heat PackIMA · Traditional | 05/10/1984SE |
| K841695 | CrawlerKNL · Traditional | 05/10/1984SE |
| K841697 | Hydro-Thero PadIRT · Traditional | 05/09/1984SE |
| K841693 | Standing Frame · Traditional | 05/09/1984SE |
| K841692 | Prone Stander · Traditional | 05/09/1984SE |
| K841691 | Split Seat Positioning ChairINN · Traditional | 05/09/1984SE |
| K834311 | Night TrainerKPN · Traditional | 03/30/1984SE |
| K833870 | Knee WalkerION · Traditional | 11/29/1983SE |
| K833177 | Glossectomy Feeding SpoonsILC · Traditional | 10/31/1983SE |
Questions and answers
When was Secura Bath Seat cleared by the FDA?
Secura Bath Seat (K812483) received a 510(k) decision of Substantially Equivalent on September 14, 1981, 14 days after the submission was received.
What is the product code of K812483?
The FDA product code is ILS – Adaptor, Hygiene, a Class I (low risk) device regulated under 21 CFR 890.5050.