# K150436: ComboRehab

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Nov 13, 2015 after 267 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: 2 generations back to K945509 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062354: Vectra Genisys VMS FR, Encore Medical L.P. (2007) Summary page 6.
- K120217: Sonicstimu Combo Therapeutic Device, Shenzhen Dongdixin Technology Co., Ltd. (2012) Summary page 6.

## Most influential descendants
- K244041: Ultrasound Therapy Workstation (XMS-UET2) (2025), 0 descendants of its own

## Indications for use
Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Pain relief, muscle spasms and joint contractures. 2. Relief of pain, muscle spasms and joint contractures that may be associated with: • Adhesive capsulitis • Bursitis with slight calcification • Myositis • Soft tissue injuries • Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic, chronic pain and joint contractures resulting from: • Capsular tightness • Capsular scarring For TENS, Interferential, premodulated(IFC), NMS and Microcurrent: 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic acute pain 3. Post-surgical acute pain Additionally for NMS, NMS Burst, Hi-Volt and Russian: 1. Relaxation of Muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For EMG To determine the activation timing of muscles for: 1. Retaining of muscle activation 2. Coordination of muscle activation An indication of the force produced by muscle for control and maintenance of muscle contractions 1. Relaxation muscle training 2. Muscle re-education For EMG triggered Stim 1. Stroke rehab by muscle re-education 2. Relaxation of muscle spasms 3. Prevention or retardation of disuse atrophy 4. Increase local blood circulation 5. Muscle re-education 6. Maintaining or increasing range of motion For DC Continuous Mode Relaxation of muscle spasm

Source page: https://510kreport.com/device/K150436
Methodology: https://510kreport.com/methodology