510(k) K915092

TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST by Progressive Medical Technology, Inc. — Product Code IRP

K915092 is an FDA 510(k) premarket notification submitted by Progressive Medical Technology, Inc. for the device "TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST". The FDA issued a decision of Substantially Equivalent on February 11, 1992. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Progressive Medical Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1992
Date Received
November 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type