FDA-Device2023-12-13Class II

NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176

Thor Photomedicine Ltd
Hazard

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

Sold states
Worldwide Distribution: US (Nationwide): Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, North Carolina, Ohio, Oregon, Texas, Utah, Virginia, West Virginia. OUS (foreign) to countries of: Australia, Canada, Netherlands, New Zealand, Singapore, United Kingdom.
Affected count
19
Manufactured in
Watermeadow House, Chesham, United Kingdom
Products
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0453-2024

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