1. “PERSONA® ADULT WHEELCHAIR”
2. “PERSONA® COMMODE CHAIR (WITH PLASTIC ARM PAD”
3. “PERSONA® ADULT WALKER”
4. “PERSONA® ROUND HANDLE STICK CANE”
5. “PERSONA® SWAN HANDLE STICK CANE”
6. “PERSONA® QUAD CANE SMALL BASE”
The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device products mentioned above have a Certificate of Medical Device Notification (CMDN) issued to Medical Center Trading Corporation, Market Authorization Holder.
Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2022-1020 dated 04 April 2022 is hereby lifted.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through email at [email protected], or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unregistered/unnotified medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.
Dissemination of this advisory to all concerned is hereby requested.