510(k) K913973

INFRARED HEAT LAMPS & MASSAGER MODEL NH-213 by National Health-Care Equipment, Inc. — Product Code ILY

K913973 is an FDA 510(k) premarket notification submitted by National Health-Care Equipment, Inc. for the device "INFRARED HEAT LAMPS & MASSAGER MODEL NH-213". The FDA issued a decision of Substantially Equivalent on November 29, 1991. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. National Health-Care Equipment, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1991
Date Received
September 6, 1991
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