# K080298: Dermabiosafe

- Pathway: 510(k) (Traditional)
- Applicant: Complete Product Resources
- Decided: Aug 5, 2008 after 182 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DermaBioSafe Neuro-muscular Electrodes are intended for use as the disposable, conductive adhesive interface between a patient's skin and the Electrical Stimulator. DermaBioSafe Neuro-muscular Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), and EMS (Electrical Muscular Stimulation). These electrodes will include the precaution statement: Federal Law restricts this device to sale by or on the order of a licensed practitioner or therapist.

Source page: https://510kreport.com/device/K080298
Methodology: https://510kreport.com/methodology