# K171798: Silverwear Silver Pro Garment Device

- Pathway: 510(k) (Traditional)
- Applicant: Media Plus, LLC
- Decided: Jun 1, 2018 after 350 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
Longest line of descent: 3 generations back to K932299 (1994). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053214: Theraknit Garment Electrode, Neurotron Medical (2005) Summary page 5.
- K141076: Garment Electrodes, Shenzhen Dongdixin Technology Co., Ltd. (2014) Summary page 5.
- K171721: Electrodes with silver conductive, Shenzhen Konmed Technology Co., Ltd. (2018). Cleared while this submission was under review Summary page 6.

## Most influential descendants
- K203158: BioWave BioWraps (2021), 2 descendants of its own
- K261522: BioWave BioWraps (2026), 0 descendants of its own
- K232995: Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe (2024), 0 descendants of its own

## Indications for use
The Silverwear SilverPro Series Conductive Garments are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The knitted garment electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include hand (glove), wrist (sleeve), elbow or arm (sleeve), knee or leg (sleeve), knee high stockings, ankle (sleeve), back band, and shoulder band.

Source page: https://510kreport.com/device/K171798
Methodology: https://510kreport.com/methodology