510(k) K912140

STAIRMASTER MODEL 6000 ERGOMETER by Tri-Tech, Inc. — Product Code ISD

K912140 is an FDA 510(k) premarket notification submitted by Tri-Tech, Inc. for the device "STAIRMASTER MODEL 6000 ERGOMETER". The FDA issued a decision of Substantially Equivalent on December 17, 1991. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Tri-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1991
Date Received
May 14, 1991
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