Disposable Tooth Brush
FDA 510(k) K823626 · Fred Sammons, Inc.
510(k) numberK823626
Submission
- Device name
- Disposable Tooth Brush
- Applicant
- Fred Sammons, Inc.
Walker, MI, US - Received
- December 6, 1982
- Decision date
- December 30, 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 |
| 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 |
More from Orthion Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
Questions and answers
When was Disposable Tooth Brush cleared by the FDA?
Disposable Tooth Brush (K823626) received a 510(k) decision of Substantially Equivalent on December 30, 1982, 24 days after the submission was received.
What is the product code of K823626?
The FDA product code is ILS – Adaptor, Hygiene, a Class I (low risk) device regulated under 21 CFR 890.5050.