Flexercycle
FDA 510(k) K904823 · Medmetric Corp.
510(k) numberK904823
Submission
- Device name
- Flexercycle
- Applicant
- Medmetric Corp.
San Diego, CA, US - Received
- October 25, 1990
- Decision date
- January 30, 1991
- 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 |
|---|---|---|
| K943197 | KT1000/S Knee Ligament ArthrometerLYH · Traditional | 03/02/1995SE |
| K942059 | KT2000 Knee Ligament ArthrometerLYH · Traditional | 09/20/1994SE |
| K904898 | Torque Frame QTF1000IKK · Traditional | 11/28/1990SE |
| K854254 | Tension-IsometerLXI · Traditional | 11/15/1985SE |
| K812806 | KT-1000 DeviceLYH · Traditional | 11/10/1981SE |
| K812713 | Drawer TestFTY · Traditional | 11/05/1981SE |
| K801572 | Surg-AssistFWZ · Traditional | 08/04/1980SE |
Questions and answers
When was Flexercycle cleared by the FDA?
Flexercycle (K904823) received a 510(k) decision of Substantially Equivalent on January 30, 1991, 97 days after the submission was received.
What is the product code of K904823?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.