# K083494: Ultima Five

- Pathway: 510(k) (Traditional)
- Applicant: Pain Management Technologies
- Decided: Jan 6, 2009 after 42 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: 2 generations back to K994266 (2000). 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)
- K040253: Easy Med TN-28 C, Easy Med Instrument Co., Ltd. (2004) Summary page 1.

## Indications for use
The Ultima FiveTM external, non-invasive, non-narcotic, electrotherapy device, is indicated, for use as an adjunctive therapy in providing symptomatic pain relief for chronic, acute, or post-operative pain. These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product.

Source page: https://510kreport.com/device/K083494
Methodology: https://510kreport.com/methodology