Standard Health Bike Model 019
FDA 510(k) K791866 · Battle Creek Equipment Co.
510(k) numberK791866
Submission
- Device name
- Standard Health Bike Model 019
- Applicant
- Battle Creek Equipment Co.
Mchenry, IL, US - Received
- September 21, 1979
- Decision date
- October 4, 1979
- 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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| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | Quinton, Inc. | 04/29/1999SE |
| K990813 | RehcorISD · Traditional | Electromed Corp. | 04/12/1999SE |
| K962855 | ULE-2, MULE-2, Hand Accessory KitISD · Traditional | Penny and Giles Biometrics , Ltd. | 12/11/1996SE |
| K952163 | David Back Clinic SystemISD · Traditional | Kinetic Resources, Inc. | 08/12/1996SE |
More from Kinetic Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K882264 | Battle Creek PillowIQK · Traditional | 08/09/1988SE |
| K863884 | Pulsestar Exercise BikeISD · Traditional | 10/23/1986SE |
| K854147 | Battle Creek Boardwalker Electric TreadmillIOL · Traditional | 12/27/1985SE |
| K854148 | Battle Creek Digi-Tracker Elctric TreadmillIOL · Traditional | 12/17/1985SE |
| K851237 | Thermophore Electric Fomentation UnitIRT · Traditional | 07/29/1985SE |
| K840280 | Road Runner Electric TreadmillIOL · Traditional | 02/04/1984SE |
Questions and answers
When was Standard Health Bike Model 019 cleared by the FDA?
Standard Health Bike Model 019 (K791866) received a 510(k) decision of Substantially Equivalent on October 4, 1979, 13 days after the submission was received.
What is the product code of K791866?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.