FDA-Device2025-05-21Class II
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
Richard Wolf GmbH
Hazard
The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
Sold states
US State: GA
Affected count
31 units
Manufactured in
Pforzheimer Str. 32, Knittlingen, Germany
Products
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1753-2025Don't want to check this manually?
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