Kaye Scoot-About, Model SB1
FDA 510(k) K924848 · Kaye Products, Inc.
510(k) numberK924848
Submission
- Device name
- Kaye Scoot-About, Model SB1
- Applicant
- Kaye Products, Inc.
Hillsborough, NC, US - Received
- September 28, 1992
- Decision date
- February 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- INM – Chair, With Casters
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3100
- Specialty
- Physical Medicine
Other 510(k)s with product code INM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063521 | Nissin Pediatric Series WheelchairINM · Traditional | Nissin Medical, Inc. | 02/05/2007SE |
| K941738 | Stryker 5050 StrechairINM · Traditional | Stryker Medical | 05/06/1994SE |
| K941569 | Caremor ClinerINM · Traditional | Winco, Inc. | 04/26/1994SE |
| K933000 | Reclining Geri Chairs W/Casters & Lap TrayINM · Traditional | Winco, Inc. | 09/30/1993SE |
| K926028 | BenchesINM · Traditional | Theradapt Products, Inc. | 03/24/1993SE |
| K926054 | Eld-Arondak ChairINM · Traditional | Al'S Woodcraft, Inc. | 03/22/1993SE |
| K926053 | Eld-Arondak ChairINM · Traditional | Alert Care, Inc. | 03/22/1993SE |
| K926025 | ChairsINM · Traditional | Theradapt Products, Inc. | 03/22/1993SE |
| K925247 | Stoneheart Roller AidINM · Traditional | Stoneheart, Inc. | 02/12/1993SE |
| K922045 | Shower ChairsINM · Traditional | Medical Device Inspection Co., Inc. | 05/26/1992SE |
More from Medical Device Inspection Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923095 | Kaye Model Kiao Pelvic/Thigh StabilizerINN · Traditional | 07/21/1992SE |
| K922061 | Chair, Adjustable, MechanicalINN · Traditional | 05/26/1992SE |
| K885330 | Wheelchair, MechanicalIOR · Traditional | 02/03/1989SE |
| K833869 | Child's WalkerITJ · Traditional | 11/29/1983SE |
| K830560 | Exerciser, Passive, Non MeasuringION · Traditional | 03/09/1983SE |
| K830466 | Bars, Parallel, ExerciseIOE · Traditional | 03/09/1983SE |
| K820591 | Mechanical ChairLBE · Traditional | 03/15/1982SE |
| K812399 | Chair, Adjustable, MechanicalINN · Traditional | 09/14/1981SE |
| K812319 | Therapy BenchIOD · Traditional | 08/31/1981SE |
| K810609 | Pediatric Position HolderFRP · Traditional | 03/20/1981SE |
Questions and answers
When was Kaye Scoot-About, Model SB1 cleared by the FDA?
Kaye Scoot-About, Model SB1 (K924848) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 137 days after the submission was received.
What is the product code of K924848?
The FDA product code is INM – Chair, With Casters, a Class I (low risk) device regulated under 21 CFR 890.3100.