# K954737: Surface Electromyograph Biofeedback Muscle Activity Device

- Pathway: 510(k) (Traditional)
- Applicant: J-Tech, Inc.
- Decided: Jul 3, 1996 after 261 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912938 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912938: Rhythm, Stellate Systems (1991) Summary page 1.
- K945630: Large Muscle Strength Gauge, J-Tech, Inc. (1995). Our OCR of the scanned summary read K944630, FDA’s number for Model 230-Sas Laser Delivery Probe (Mnlase, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Tracker Microprocessor and Tracker PC Software of the Large Muscle…”.

## Indications for use
The JTech Dynatrack Surface Electromyograph is a biofeedback device that provides a visual signal corresponding to the status of a patient’s muscle activity. Healthcare professionals can use the machine to monitor the patient’s muscle activity. This is a precise biofeedback instrument for quick and accurate assessment and recording of the bioelectric muscie signal. It is compliant with the National Bureau of Standards calibration standards for microvolts.

Source page: https://510kreport.com/device/K954737
Methodology: https://510kreport.com/methodology