Bathtub Transfer Bench
FDA 510(k) K821010 · Guardian Products Co., Inc.
510(k) numberK821010
Submission
- Device name
- Bathtub Transfer Bench
- Applicant
- Guardian Products Co., Inc.
Mchenry, IL, US - Received
- April 12, 1982
- Decision date
- April 21, 1982
- 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 |
| K813629 | BK-6111 Hi-D Transfer BoardIKX · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
More from Fred Sammons, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915108 | Folding WheelchairIOR · Traditional | 01/13/1992SE |
| K842650 | Wall Grab Bars 98130-98136IKX · Traditional | 08/10/1984SE |
| K842649 | Bath Tub Transfer ChairIKN · Traditional | 08/10/1984SE |
| K842651 | Commode Chair 98200ILS · Traditional | 08/07/1984SE |
| K821009 | Bathtub Grab BarILS · Traditional | 04/21/1982SE |
| K790299 | Forearm-CaneIPS · Traditional | 02/21/1979SE |
| K772049 | Walking AidITJ · Traditional | 11/11/1977SE |
Questions and answers
When was Bathtub Transfer Bench cleared by the FDA?
Bathtub Transfer Bench (K821010) received a 510(k) decision of Substantially Equivalent on April 21, 1982, 9 days after the submission was received.
What is the product code of K821010?
The FDA product code is IKX – Aid, Transfer, a Class I (low risk) device regulated under 21 CFR 890.5050.