Grab Bar
FDA 510(k) K780935 · Orthopedic Equipment Co., Inc.
510(k) numberK780935
Submission
- Device name
- Grab Bar
- Applicant
- Orthopedic Equipment Co., Inc.
Mchenry, IL, US - Received
- June 7, 1978
- Decision date
- June 19, 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 |
|---|---|---|
| K834035 | Universal Self-Aligning Acetabular ComJDI · Traditional | 06/19/1984SE |
| K841189 | Oec/Rezaian Spinal FixatorKWQ · Traditional | 05/16/1984SE |
| K800530 | Schlein Tri-Surface AnkleHSN · Traditional | 04/02/1980SE |
| K781445 | SpreaderGAD · Traditional | 09/27/1979SE |
| K790247 | Tourniquet Test Gage · Traditional | 02/26/1979SE |
| K790209 | Filter System, Altner DisposableGAZ · Traditional | 02/26/1979SE |
| K781451 | Flat WrenchHXS · Traditional | 09/27/1978SE |
| K781450 | DriversGFC · Traditional | 09/27/1978SE |
| K781449 | Harrington Spinal ElevatorGEG · Traditional | 09/27/1978SE |
| K781448 | Harrington Hook ClampGEN · Traditional | 09/27/1978SE |
Questions and answers
When was Grab Bar cleared by the FDA?
Grab Bar (K780935) received a 510(k) decision of Substantially Equivalent on June 19, 1978, 12 days after the submission was received.
What is the product code of K780935?
The FDA product code is IKX – Aid, Transfer, a Class I (low risk) device regulated under 21 CFR 890.5050.