iButton FDA clearance
Patricia Rogel
Description
Collection
Title:
iButton FDA clearance
Creator:
Patricia Rogel
Date:
5/4/2021
Text:
Hi,
It is routine practice to place an iButton in spinal orthoses. Are they approved by the FDA for use in medical devices on humans? If so, can someone tell me the link or info – I have a parent asking.
Thank you,
Pat
Patricia Rogel, CO, LO, OTR/L
Chicago Pediatric Orthotics
Concourse Office Plaza, Tower 1
4711 Golf Road, Suite 1055
Skokie, IL 60076
224-470-8550 (ph)
224-470-8553 (fax)
<URL Redacted> < <URL Redacted> >
If you are a patient receiving this email, you have signed a release allowing Chicago Pediatric Orthotics to email you directly. HIPAA guidelines state that if a patient has been made aware of the risks of unencrypted email, and that same patient provides consent to receive health information via email, then a health entity may send that patient personal medical information via unencrypted email. We have your signed consent for email communication, therefore, this is in compliance with the Breach Notification Requirements under Section 13402 of Title X111 (Health Information Technology for Economic and Clinical Health Act) of the American Recovery and Reinvestment Act of 2009. Email correspondence related to care will be saved in patient’s medical record.
CONFIDENTIALITY NOTICE: This e-mail message and any attachments are for the sole use of the intended recipient(s) and may contain proprietary, confidential, trade secret or privileged information. Any unauthorized review, use, disclosure or distribution is prohibited and may be a violation of law. If you are not the intended recipient or a person responsible for delivering this message to an intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
It is routine practice to place an iButton in spinal orthoses. Are they approved by the FDA for use in medical devices on humans? If so, can someone tell me the link or info – I have a parent asking.
Thank you,
Pat
Patricia Rogel, CO, LO, OTR/L
Chicago Pediatric Orthotics
Concourse Office Plaza, Tower 1
4711 Golf Road, Suite 1055
Skokie, IL 60076
224-470-8550 (ph)
224-470-8553 (fax)
<URL Redacted> < <URL Redacted> >
If you are a patient receiving this email, you have signed a release allowing Chicago Pediatric Orthotics to email you directly. HIPAA guidelines state that if a patient has been made aware of the risks of unencrypted email, and that same patient provides consent to receive health information via email, then a health entity may send that patient personal medical information via unencrypted email. We have your signed consent for email communication, therefore, this is in compliance with the Breach Notification Requirements under Section 13402 of Title X111 (Health Information Technology for Economic and Clinical Health Act) of the American Recovery and Reinvestment Act of 2009. Email correspondence related to care will be saved in patient’s medical record.
CONFIDENTIALITY NOTICE: This e-mail message and any attachments are for the sole use of the intended recipient(s) and may contain proprietary, confidential, trade secret or privileged information. Any unauthorized review, use, disclosure or distribution is prohibited and may be a violation of law. If you are not the intended recipient or a person responsible for delivering this message to an intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
Citation
Patricia Rogel, “iButton FDA clearance,” Digital Resource Foundation for Orthotics and Prosthetics, accessed November 5, 2024, https://library.drfop.org/items/show/255387.
