510(k) K926170
K926170 is an FDA 510(k) premarket notification submitted by Stairmaster Sports/Medical Products, Inc. for the device "STEPMILL EXERCISE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1993
- Date Received
- November 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exerciser, Measuring
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type