# K123399: Myovision 3.0 Wirefree System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biometrics, Inc.
- Decided: Aug 1, 2013 after 269 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971407 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023209: Insight Millennium Iii, Fasstech (2003) Summary page 1.

## Indications for use
The PBI MyoVision 3G WireFree System is indicated to provide the clinician with EMG activity, skin temperature, angles of the patient's motion information during therapies that include muscle relaxation training and re-education.

Source page: https://510kreport.com/device/K123399
Methodology: https://510kreport.com/methodology