# K982544: Rich-Mar US500, US750, US1000 Therapeutic Unltrasound Devices

- Pathway: 510(k) (Traditional)
- Applicant: Rich-Mar Corp.
- Decided: Nov 19, 1998 after 121 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- Recalls of this device: none
- 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.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: 1) Relief of pain 2) Muscle Spasms 3) Joint contractures But NOT for the treatment of malignancies

Source page: https://510kreport.com/device/K982544
Methodology: https://510kreport.com/methodology
