510(k) K052063

HUANQIU HEATING LAMP by A & A Medical Supplies, Inc. — Product Code ILY

K052063 is an FDA 510(k) premarket notification submitted by A & A Medical Supplies, Inc. for the device "HUANQIU HEATING LAMP". The FDA issued a decision of Substantially Equivalent on September 30, 2005. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. A & A Medical Supplies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2005
Date Received
July 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type