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Devices
Device Recall LumiWave Infrared lamp
Model / Serial
Catalog # LW1X4, all units, all lots
Product Classification
Physical Medicine Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution --- including the states of CA, CO, IL, MA, MD, MI, NC, FL, PA, TX, UT, WA.
Product Description
LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
Manufacturer
Biocare Systems Inc.
1 Event
Recall of Device Recall LumiWave Infrared lamp
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Manufacturer
Biocare Systems Inc.
Manufacturer Address
Biocare Systems Inc., 9853 Paperflower Drive, Parker CO 80138
Manufacturer Parent Company (2017)
Biocare Systems Inc
Source
USFDA
Language
English
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