Chair, Adjustable, Mechanical
FDA 510(k) K812399 · Kaye Products, Inc.
510(k) numberK812399
Submission
- Device name
- Chair, Adjustable, Mechanical
- Applicant
- Kaye Products, Inc.
Mchenry, IL, US - Received
- August 20, 1981
- Decision date
- September 14, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- INN – Chair, Adjustable, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3100
- Specialty
- Physical Medicine
Other 510(k)s with product code INN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945650 | SpiffyINN · Traditional | Thames Valley Children'S Centre | 12/19/1994SE |
| K942397 | Theradapt Highchair/Stroller InsertINN · Traditional | Theradapt Products, Inc. | 06/22/1994SE |
| K930520 | Theradapt(R) Adjustable Classroom ChairINN · Traditional | Theradapt Products, Inc. | 03/24/1993SE |
| K923753 | Able Generation Therapy Tilt BenchINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923752 | Able Generation Play ChairINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923750 | Able Generation Booster ChairINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923095 | Kaye Model Kiao Pelvic/Thigh StabilizerINN · Traditional | Kaye Products, Inc. | 07/21/1992SE |
| K922061 | Chair, Adjustable, MechanicalINN · Traditional | Kaye Products, Inc. | 05/26/1992SE |
| K921272 | Activity ChairINN · Traditional | Rifton Equipment For the Handicapped | 04/07/1992SE |
| K904069 | Broda Nursing Care ChairINN · Traditional | Broda Ent., Inc. | 09/17/1990SE |
More from Broda Ent., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924848 | Kaye Scoot-About, Model SB1INM · Traditional | 02/12/1993SE |
| 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 |
| K812319 | Therapy BenchIOD · Traditional | 08/31/1981SE |
| K810609 | Pediatric Position HolderFRP · Traditional | 03/20/1981SE |
Questions and answers
When was Chair, Adjustable, Mechanical cleared by the FDA?
Chair, Adjustable, Mechanical (K812399) received a 510(k) decision of Substantially Equivalent on September 14, 1981, 25 days after the submission was received.
What is the product code of K812399?
The FDA product code is INN – Chair, Adjustable, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3100.