510(k) K992733

AKRON ATP9 TRACTION MACHINE by Huntleigh Technology, Inc. — Product Code ITH

K992733 is an FDA 510(k) premarket notification submitted by Huntleigh Technology, Inc. for the device "AKRON ATP9 TRACTION MACHINE". The FDA issued a decision of Substantially Equivalent on November 10, 1999. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Huntleigh Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1999
Date Received
August 13, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type