Stationary Exercise Bicycle
FDA 510(k) K834098 · Engineering Dynamics Corp.
510(k) numberK834098
Submission
- Device name
- Stationary Exercise Bicycle
- Applicant
- Engineering Dynamics Corp.
Mchenry, IL, US - Received
- November 28, 1983
- Decision date
- December 27, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ISD – Exerciser, Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
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More from Kinetic Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871494 | Uppercycle Stationary Exercise MachinesISD · Traditional | 05/06/1987SE |
| K844578 | Non-Magnetic Examination Table for Magnetic ResonaFPO · Traditional | 05/14/1985SE |
| K842108 | Universal Examination TableGZO · Traditional | 07/17/1984SE |
| K828313 | Digital Radiography Examination Table · Traditional | 10/07/1982SE |
| K802254 | General Ultrasound Exam. TableIYN · Traditional | 11/26/1980SE |
| K790545 | Stress Testing System, Lateral TiltingDRT · Traditional | 06/06/1979SE |
| K790544 | Stress Testing System, Multi-PositionDRT · Traditional | 06/05/1979SE |
| K790466 | U-MatIYX · Traditional | 03/28/1979SE |
| K790499 | Multiple Pinhole Tomographic CollimoterIYX · Traditional | 03/26/1979SE |
Questions and answers
When was Stationary Exercise Bicycle cleared by the FDA?
Stationary Exercise Bicycle (K834098) received a 510(k) decision of Substantially Equivalent on December 27, 1983, 29 days after the submission was received.
What is the product code of K834098?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.