# K063135: Sonic-Stim

- Pathway: 510(k) (Traditional)
- Applicant: Naimco, Inc.
- Decided: Feb 5, 2007 after 112 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- 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 K010749 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031077: Vectra Epr System and Intelect Epr System, Chattanooga Group (2003) Summary page 1.
- K010749: Electro Neuromuscular Stimulator, Model NMS-Digital, Biomedical Life Systems, Inc. (2001) Summary page 1.

## Indications for use
For Russian, and High Volt * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Increase local blood circulation * Muscle re-education * Maintaining or increasing range of motion * Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For interferential and premodulated interferential * Symptomatic relief of chronic, intractable pain * Management of pain associated with post-traumatic or post-operative conditions For Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: * Pain Relief * Reduction of muscle spasms * Joint contractures For TENS and EMS * Symptomatic relief and management of chronic intractable pain * Adjunctive treatment in the management of post surgical and post traumatic acute pain condition

Source page: https://510kreport.com/device/K063135
Methodology: https://510kreport.com/methodology