# K063728: TNN-DU810 Non-Invasive Subdermal Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Tech Medical Systems, Ltd.
- Decided: Apr 4, 2007 after 110 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: 3 generations back to K984142 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052340: DU857 Dual Frequency Ultrasound Therapy  and Muscle Stimulator System, Alfa Tech Medical Systems, Ltd. (2005) Summary page 4.
- K024307: Dermosonic Non-Invasive Subdermal Therapy System, Sybaritic, Inc. (2003) Summary page 2.

## Indications for use
Therapeutic Ultrasound: 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase of blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques Neuromuscular Stimulation: 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles 4. Increase of blood flow in the treatment area. 5. Prevention or retardation of disuse atrophy in post-injury type conditions 6. Muscle re-education 7. Maintaining or increasing range of motion Therapeutic Massager: 1. Relieves muscle spasms 2. Provides temporary relief of minor muscle aches and pains 3. Temporarily improves local blood circulation 4. Temporarily reduces the appearance of cellulite

Source page: https://510kreport.com/device/K063728
Methodology: https://510kreport.com/methodology