FDA issues warning letter to a therapeutic vibrator

Medical Devices Directory Forums Product & Service FDA issues warning letter to a therapeutic vibrator

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    FDA recently released warning letter to a Santa Ana CA USA based company. FDA pointed out that a therapeutic vibrator from this firm failed obtaining approved application for premarket approval nor an approved application for an investigational device exemption (IDE) before marketing the device. FDA also found evidence that the therapeutic vibrator is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5975 (therapeutic vibrator), and 21 CFR 890.5740 (powered heating pad).

    To view the FDA warning letter please follow this link

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