Section 6 - Formav Treatment Information; Indications For Use; Contraindications - InMode VOTIVA Operator's Manual

Section 6 - FormaV Treatment
Information

Indications for Use

The Votiva System with FormaV Handpiece is a genital device for therapeutic use, an
electrically operated device intended and labeled for therapeutic use in the treatment of
sexual disfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the
pelvic floor to increase muscle tone). It is also intended for treatment of selected medical
conditions such as relief of minor muscle aches and pain, relief of muscle spasm,
temporary improvement of local blood circulation.

Contraindications

Contraindications in the use of the System include:
• Active electrical implant in any region of the body
• Vaginal or Pelvic area surgery within the last 12 months
• Metal implants or mesh in the treatment area
• History of genital herpes
• Uterine prolapse, cystocele or rectocele greater than Grade 1
• Urinary tract infection
• Pelvic tract infection
• Pelvic infection
• Active malignancy or cancer treatment within the last five years
• Melanoma
• Dysplastic nevi in the treatment zone
• Malignancy requiring lymph node dissection of the pelvic area or significant
lower lymphatic drainage problems
• Concurrent illnesses such as significant cardiac disease, diabetes, autoimmune
disease or any other concurrent illness which may impeded the wound healing
response or disease, which the physician deems may interfere with proper
recovery
• History of epidermal or dermal disorders involving collagen or microvasculature
• Pregnancy and nursing
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