# K041390: Diamond Medistim

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Systems USA, Inc.
- Decided: Feb 9, 2005 after 260 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 K926410 (1993). 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)
- K926410: Ultratone 8+ & 20, Bowater Research, Inc. (1993) Summary page 2.

## Indications for use
1. Relaxation of muscle spasms; 2. Prevention or retardation of disuse atrophy; 3. Increasing local blood circulation; 4. Muscle re-education; 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of molion. When the device is used in a manner that delivers continuous, uninterrupted pulses, it is indicated only for the relaxation of muscle spasms. The Variable Stim output mode delivers continuous, uninterrupted pulses. The Auto Stim output mode delivers bursts of pulses that are interrupted with I second "off" periods.

Source page: https://510kreport.com/device/K041390
Methodology: https://510kreport.com/methodology