Impossible is the Degree of Difficulty

March 10th, 2005

Vibrotraining Device is registered with Federal Drug Administration (FDA).

March 1st, 2005

Vibrotraining Device was approved by FDA (Federal Drug Administration) as device for reduction in muscular pain. Vibrotraining Device is the first vibration device approved by FDA. It opens the door for medical insurance companies to cover treatment expenses using Vibrotraining Device.

Our device falls within Title 21 of the Code of Federal Regulations (CFR) 890.5975, Therapeutic vibrator (Product Code - IRO). A therapeutic vibrator is a Class I type device, exempt from the premarket notification [510(k)] requirements of the Act, subject to the limitations to the exemption found in 21 CFR 890.9.

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