FDA Classifies Massager, Surgical Instrument as Class II

The FDA has categorized an internal therapeutic massager and an orthopedic surgical instrument used for osteochondral implants as Class II devices, assigning them special controls.

The special controls for the massager include labeling with adequate directions for use, non-clinical performance testing demonstrating electromagnetic compatibility, electrical safety and mechanical safety, and non-clinical performance testing showing the device performs as intended under anticipated usage conditions.

The orthopedic instrument must have geometric technical specifications proving it can safely position and place the implant, biocompatible patient-contacting parts, and labeling that identifies implants and instruments validated for use together, and validated methods and instructions for reprocessing any reusable parts.

Read the classification order for the internal massager here: www.fdanews.com/10-25-19-MDPhysicalMedicineTherapeutic.pdf.

Read the classification order for the surgical instrument here: www.fdanews.com/10-25-19-MDOrthopedic.pdf.