Quinton Medtrack CR Plus Treadmill
FDA 510(k) K990866 · Quinton, Inc.
510(k) numberK990866
Submission
- Device name
- Quinton Medtrack CR Plus Treadmill
- Applicant
- Quinton, Inc.
Bothell, WA, US - Received
- March 16, 1999
- Decision date
- April 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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Questions and answers
When was Quinton Medtrack CR Plus Treadmill cleared by the FDA?
Quinton Medtrack CR Plus Treadmill (K990866) received a 510(k) decision of Substantially Equivalent on April 29, 1999, 44 days after the submission was received.
What is the product code of K990866?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.