Sense System with IBT Electrodes

GUDID 00850004850480

Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand with Axon Elbow

INFINITE BIOMEDICAL TECHNOLOGIES, LLC

Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis Myoelectric hand prosthesis
Primary Device ID00850004850480
NIH Device Record Key707b09fe-5535-4b7f-a268-fc95098bbe09
Commercial Distribution StatusIn Commercial Distribution
Brand NameSense System with IBT Electrodes
Version Model Number70101-24
Company DUNS037376022
Company NameINFINITE BIOMEDICAL TECHNOLOGIES, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com
Phone4434517175
Emailsupport@i-biomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004850480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-03
Device Publish Date2021-02-23

On-Brand Devices [Sense System with IBT Electrodes]

00850004850480Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand
00850004850473Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand
00850004850466Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand
00850004850459Surface electrodes for Electromyography with Pattern Recognition controller - Michelangelo Hand
00850004850442Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid
00850004850411Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid
00850004850404Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid
00850004850374Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid
00850004850343Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850336Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850329Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850305Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850299Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850282Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wi
00850004850268Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (wi
00850004850251Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (w
00850004850244Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (wi
00850004850237Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (with gr
00850004850220Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (with gr
00850004850213Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (with gr
00850004850206Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid
00850004850190Surface electrodes for Electromyography with Pattern Recognition controller - Espire Pro/Hybrid
00850004850169Surface electrodes for Electromyography with Pattern Recognition controller - U3+ Elbow
00850004850152Surface electrodes for Electromyography with Pattern Recognition controller - Boston TMR elbow
00850004850145Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850138Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850121Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850114Surface electrodes for Electromyography with Pattern Recognition controller - E2 Elbow (Hand wit
00850004850107Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow
00850004850091Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow
00850004850084Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow
00850004850077Surface electrodes for Electromyography with Pattern Recognition controller - Passthrough Elbow
00850004850060Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (wi
00850004850053Surface electrodes for Electromyography with Pattern Recognition controller - Hand and Wrist (wi
00850004850046Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (withou
00850004850039Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (with gr
00850004850183Surface electrodes for Electromyography with Pattern Recognition controller - Hand and wrist (TA
00850004850176Surface electrodes for Electromyography with Pattern Recognition controller - Hand Only (TASKA w

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.