MUSCLE STIMULATORS

Primary DI

01220000221819

Basic UDI-DI Code

122000022PROJ52KQ

Reference

Perineal Massage Wand

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Fridababy, LLC

Intended Use: The Frida Mom Perineal Massage Wand is intended to massage the perineal area to help reduce the occurrence of perineal tearing. It is intended to be used at home by the expecting mother. Contraindications: If you experience any signs of irritation, allergic reaction, unfamiliar bleeding or discharge, discontinue use immediately. If symptoms persist, consult a doctor. Warnings and Precautions: WARNING: Read full instructions before use. For use on the perineal area only. Wash before and after each use to reduce the chance of infection. Do not use if the wand becomes damaged. If you experience any signs of irritation, allergic reaction, unfamiliar bleeding or discharge, discontinue use immediately. If symptoms persist, consult a doctor. Store in the included case or storage bag in a cool dry place. Consult a medical professional before performing a perineal massage if you have a vaginal infection such as thrush or yeast infection or have a sexually transmitted disease. Do not share the wand or use a wand that was used by another person. Discontinue use and speak with your healthcare provider if you experience discomfort, burning or itching. Do not use if the wand is damaged in any way. Use only as directed. For external use only. Not for use as a pelvic floor massage tool or other internal device. Keep out of the reach of children. Not for use by persons with reduced physical, mental, or sensory abilities. Any serious incident that has occurred in relation to the device should be reported to Frida and the local competent authority. Caution: This product contains natural rubber latex which may cause allergic reactions. If irritation occurs or symptoms do not improve, consult a medical professional. Caution: Consult your healthcare provider regarding when you should start and how often you should be massaging.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).