510(k) K991503

SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 by United Pacific Co., Ltd. — Product Code ILY

K991503 is an FDA 510(k) premarket notification submitted by United Pacific Co., Ltd. for the device "SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36". The FDA issued a decision of Substantially Equivalent on July 28, 1999. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. United Pacific Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1999
Date Received
April 29, 1999
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