510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060134Substantially Equivalent

Apollo Ir Heat Lamp System

Apollo Physical Therapy Products International, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060134 is the FDA 510(k) clearance record for APOLLO IR HEAT LAMP SYSTEM, a class II device, cleared for Apollo Physical Therapy Products International on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list one 510(k) clearance for Apollo Physical Therapy Products International. As of , FDA records show one recall naming K060134.

Clearance record

Decision date
Received
(62 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Apollo Physical Therapy Products International 12101 Cullen Blvd., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ILY

Trailing 12 months
1 clearance under product code ILY in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ILY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260