# K964083: Ultratherm (908)

- Pathway: 510(k) (Traditional)
- Applicant: Sie-Med, Inc.
- Decided: Apr 3, 1997 after 174 days
- Product code: IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5290
- 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 K862589 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862589: Ultratherm 808 I, Elmed, Inc. (1986) Summary page 1.

## Indications for use
The Ultratherm 9081 is a shortwave diathermy device mtended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.

Source page: https://510kreport.com/device/K964083
Methodology: https://510kreport.com/methodology