APOLLO IR HEAT LAMP SYSTEM— 510(k) K060134

Name: FDA 510(k) clearance K060134
Creator: U.S. Food and Drug Administration
Published: 2006-03-21

Substantially Equivalent

Apollo Physical Therapy Products International

FDA 510(k) clearance K060134 for APOLLO IR HEAT LAMP SYSTEM, Substantially Equivalent on 2006-03-21. Applicant: Apollo Physical Therapy Products International. Device class: 2.

Clearance details

Applicant: Apollo Physical Therapy Products International
Product code: Code ILY
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2006-01-18
Decision date: 2006-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ILY

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K060134

K-number listed on FDA's recall record

Z-1250-2015 — Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.Class II·Terminated·Pivotal Health Solutions·20141217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060134.

Data sourced from openFDA. This site is unofficial and independent of the FDA.