# K961141: Easy Flex Tens/Fes/MNS Electrodes 2 Round Model 8200/2X2 Model 8220

- Pathway: 510(k) (Traditional)
- Applicant: Uni-Patch, Inc.
- Decided: May 10, 1996 after 50 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic, Comfort-Ease®, TENS & Neuro-Muscular Stimulation Electrodes: named in the summary without a submission number
- (no number) 3M, Myocare®, Muscle Stimulation Electrodes: named in the summary without a submission number
- (no number) LMI TENS/EMS Electrodes with Promeon RG-60 Series gel: named in the summary without a submission number

## Most influential descendants
- K040400: Myo-Trode SG Disposable Electrode (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K961141
Methodology: https://510kreport.com/methodology