# K973223: Stellar Model HS-04

- Pathway: 510(k) (Traditional)
- Applicant: Stellar Medical Corp.
- Decided: Feb 18, 1998 after 175 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 K926510 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953136: RS-4M, Rs Medical (1995) Summary page 1.
- K926510: Staodyn Ems+2, Staodyne, Inc. (1993) Summary page 1.
- K963887: PT-Pac Portable Heating Pad, Anthony A. Chiurco (1997) Summary page 1.

## Most influential descendants
- K990697: RS-4V Muscle Stimulator (1999), 0 descendants of its own

## Indications for use
The Stellar Model HS-04 stimulator mode is indicated for use in repeatedly contracting muscles using pulsed electrical currents for muscle reeducation, maintaining or increasing range of motion, relaxing muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and immediate post-surgical prevention of venous thrombosis in the calf. The Stellar Model HS-04 interferrential mode is indicated for use in post-surgical acute pain and edema, post-traumatic acute pain and edema, reduction of inflamation, increasing local blood circulation, maintaining or increasing range of motion, and relaxing muscle spasms. The Stellar Model HS-04 heating-mode is indicated for heating of a body region for the relief of minor muscular or joint pain.

Source page: https://510kreport.com/device/K973223
Methodology: https://510kreport.com/methodology