CRYOTHERAPY AND THERMOTHERAPY DEVICES

Primary DI

01220000227781

Basic UDI-DI Code

122000022PROJ27KR

Reference

C-Section Recovery Band

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Fridababy, LLC

Intended Use: The Frida Mom C-Section Recovery Band is intended to be used by persons who have undergone cesarian section delivery to provide hot or cold therapy, support, and cushioning to healing cesarian section incisions. Contraindications: There are no contraindications for the Frida Mom C-Section Recovery Band. Warnings and Precautions: Therapy Band Do not use directly over incision, cover first with a fresh bandage. Consult a healthcare professional immediately if you see signs of irritation, bleeding, allergic reaction, or burns. Hot/Cold Gel Pack • Do not overheat as it may cause burns or rupture the pack • Use only as directed • Keep out of reach of children • For external use only • If swallowed, seek immediate medical help or contact poison control • If skin irritation occurs or if symptoms do not improve, contact a medical professional • Avoid applying the pack directly to the skin at extreme temperatures • Avoid risk of heat or freeze burn by putting the pack in the band or by wrapping it in a cover before applying it to the skin • Do not apply heat or cold therapy for more than 15-20 minutes at a time • Hot and cold gel pack not intended to be used with food • Discontinue use and dispose of if punctured or ripped

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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