# K030140: Duomed, Series 500, (Models ID 500, FL 500)

- Pathway: 510(k) (Traditional)
- Applicant: Duomed, Inc.
- Decided: Mar 18, 2003 after 63 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924876 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924876: Tens Device for Relief of Chronic Pain, Modified, Graham-Field, Inc. (1994) Summary page 1.
- K002297: Yoramed, Model T-202, United Yoram Distributors, Inc. (2001)

## Indications for use
Indicated for the symptomatic relief and management of chronic (long term) intractable pain and/or as an adjunct treatment in the management of post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K030140
Methodology: https://510kreport.com/methodology