# K092627: CT2011 Sonicstimu Pain Relief Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Jan 14, 2010 after 141 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 K984142 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071137: Sonicator Plus 940, Model ME940, Mettler Electronics Corp. (2007) Summary page 2.

## Indications for use
Therapeutic Ultrasound 1. Pain relief 2. Reduction of muscle spasm 3. Joint contractures Transcutaneous Electrical Nerve Stimulation 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic pain 3. Post-surgical pain

Source page: https://510kreport.com/device/K092627
Methodology: https://510kreport.com/methodology