Neurology · 510(k) · 2023
NeuroRPM
New Touch Digital Inc.. Cleared by FDA on 17 March 2023 under submission K221772, product code GYD (transducer, tremor). What FDA's record says, in FDA's words.
Device record · K221772
- Device. NeuroRPMDEVICE
- Company. New Touch Digital Inc.COMPANY
- Decision. 17 March 2023, 510(k), substantially equivalent (traditional review); received 21 June 2022DECISION
- Panel. NeurologyPANEL
- Product code. GYD, Transducer, TremorCODE
- Regulation. 21 CFR 882.1950, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia. It includes a medication reminder, an event marker and is intended to monitor activity associated with movement during sleep. The device is indicated for use in individuals 46 to 83 years of age. NeuroRPM is intended to quantify movement disorder symptoms during wake periods in adult patients 46 to 85 years of age with Parkinson's disease. These symptoms include tremor, bradykinesia, and dyskinesia. NeuroRPM is intended for clinic and home environments. Same intended use of quantifying movement disorder symptoms. Wearable Device Proprietary watch with accelerometer. Apple Watch triaxial inertial measurement unit. Both use wrist-worn devices to measure movement. Algorithm Equation with data in frequency domain. Machine learning model with data in time and frequency domain. Both algorithms are deterministic and generate
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 3 reports filed against devices carrying product code GYD. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
15 September 2023 · Malfunction · PARKINSONS DISEASE PROGRAMING · UNK · report MW5145721
I AM NOT CERTAIN BUT I DO THINK THERE MAY BE A PROBLEM WITH THE DEVICE BEING USED FOR IMPROPER FUNCTIONS. FOR THE RECORD THIS IS JUST AN OPINION/ ASSUMPTION. I RECENTLY BOUGHT A NEW APPLE WATCH, IT WAS DEFECTIVE BECAUSE OF A 3RD PARTY PROGRAM THAT WAS INSTALLED THAT HAD TO DO WITH PARKINSONS DISEASE. I ALSO RECENTLY FOUND A REMOTE WORK STATION CONNECTED TO MY LAPTOP WHICH WAS HACKING MY ACCOUNTS. MY BANK, MY PHONE AND SECURE ACCESS FOR DOL AND UNEMPLOYMENT BENEFITS. I HAVE HACKED ACCOUNTS AND […]
12 August 2023 · Malfunction · GKC WATCH · GKC MANUFACTURING PTY LTD · report MW5130559
IT WAS REPORTED THE GKC WATCH WAS RETURNED AFTER THE VISIT OCCURRED AND THE TABLET WOULD NOT UPLOAD DATA FROM THE WATCH PROPERLY. THE PKG CLINIC APP ON THE TABLET KEPT CRASHING AND WOULD NOT WORK. IT WAS INDICATED THAT THE ISSUE WAS RELATED TO THE PKG WATCH. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
12 August 2023 · Malfunction · PERSONAL KINETIGRAPH (PKG) TABLET · GLOBAL KINETICS · report MW5130700
IT WAS REPORTED THERE WAS A PROBLEM WITH THE PKG TABLET. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. IT WAS NOTED THE APPLICATION WAS OPENED TO UPLOAD A WATCH THE APPLICATION WOULD NOT OPEN. IT WOULD ACT LIKE IT WOULD OPEN AND THEN GO BACK TO THE MAIN SCREEN. AFTER TRYING TO OPEN IT A FEW TIMES A SCREEN WOULD POP UP SAYING "PKG CLINIC KEEPS STOPPING." THE DEVICE WAS TURNED OFF SEVERAL TIMES AND RESTARTED BUT NOTHING […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code GYD, in Neurology, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.