# K990787: TRIO 300

- Pathway: 510(k) (Traditional)
- Applicant: Ito Co., Ltd.
- Decided: Oct 20, 1999 after 224 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: 2 generations back to K912178 (1991). 6 ancestors in all.
78 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981976: Acutron Mentor Model 961, Microcurrent Research, Inc. (1998) Summary page 1.
- K972244: NT2000, Bio-Medical Research, Ltd. (1998) Summary page 1.

## Most influential descendants
- K023231: Elfcare Device, Models 314A Through 314G (2003), 63 descendants of its own
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own
- K090094: Zeltiq System (2009), 32 descendants of its own

## Indications for use
The TENS and Microcurrent modes of the Trio 300 are indicated for the symptomatic relief of chronic intractable pain. They are also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K990787
Methodology: https://510kreport.com/methodology