Board, Transfer, Fender
FDA 510(k) K781201 · Fred Sammons, Inc.
510(k) numberK781201
Submission
- Device name
- Board, Transfer, Fender
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- July 14, 1978
- Decision date
- July 31, 1978
- 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 |
| K823154 | Shower Stool W/HandlesIKX · Traditional | Orthion Corp. | 11/05/1982SE |
| 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 |
More from Guardian Products Co., Inc.
| 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 Board, Transfer, Fender cleared by the FDA?
Board, Transfer, Fender (K781201) received a 510(k) decision of Substantially Equivalent on July 31, 1978, 17 days after the submission was received.
What is the product code of K781201?
The FDA product code is IKX – Aid, Transfer, a Class I (low risk) device regulated under 21 CFR 890.5050.