# K962681: Ecogel 300 Tens Gel

- Pathway: 510(k) (Traditional)
- Applicant: Eco-Med Pharmaceuticals, Inc.
- Decided: Oct 4, 1996 after 86 days
- Product code: GYB (Media, Electroconductive)
- Device class: 2
- Regulation: 21 CFR 882.1275
- Recalls of this device: 1 (1 Class I)
- 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 24, 2021 · Class I · Z-0068-2022: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Source page: https://510kreport.com/device/K962681
Methodology: https://510kreport.com/methodology