510(k) K073675

T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP by Gaymar Industries, Inc. — Product Code ILO

K073675 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP". The FDA issued a decision of Substantially Equivalent on May 8, 2008. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2008
Date Received
December 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type