Bars, Parallel, Exercise
FDA 510(k) K830466 · Kaye Products, Inc.
510(k) numberK830466
Submission
- Device name
- Bars, Parallel, Exercise
- Applicant
- Kaye Products, Inc.
Mchenry, IL, US - Received
- February 15, 1983
- Decision date
- March 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOE – Bars, Parallel, Exercise
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5370
- Specialty
- Physical Medicine
Other 510(k)s with product code IOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K770611 | Parallel BarsIOE · Traditional | Will Ross Co. | 04/08/1977SE |
More from Will Ross Co.
| 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 |
| 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 Bars, Parallel, Exercise cleared by the FDA?
Bars, Parallel, Exercise (K830466) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 22 days after the submission was received.
What is the product code of K830466?
The FDA product code is IOE – Bars, Parallel, Exercise, a Class I (low risk) device regulated under 21 CFR 890.5370.