# K001166: Ultra V Therapeutic Ultrasound

- Pathway: 510(k) (Traditional)
- Applicant: Excel Tech., Ltd.
- Decided: Jul 7, 2000 after 88 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- 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 K923076 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923076: Ultra SX, Excel Tech., Ltd. (1993) Summary page 1.

## Cited in the summary but kept off the family tree
- K944065: Excel Tech Ultra Max (formerly called Ultra SX). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K040121: Dermawave 5000 Combi Max System (2004), 0 descendants of its own
- K023050: Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound System, Reliant BTL 5000 Combi (2003), 0 descendants of its own

## Indications for use
The Ultra V provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with the chronic and sub-chronic conditions of: 1. Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis. 2. Soft tissue injurics and shortened tendons due to past injurics and scar tissue 3. Joint contractures resulting from capsular tightness and scarring.

Source page: https://510kreport.com/device/K001166
Methodology: https://510kreport.com/methodology