FDA-Device2019-08-28Class III
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Hazard
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Sold states
Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
Affected count
2079 units
Manufactured in
12011 Mosteller Rd, N/A, Cincinnati, OH, United States
Products
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2291-2019Don't want to check this manually?
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