510(k) K926170

STEPMILL EXERCISE SYSTEM by Stairmaster Sports/Medical Products, Inc. — Product Code ISD

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