# K053041: Med Sculpt

- Pathway: 510(k) (Traditional)
- Applicant: General Project S.R.L.
- Decided: Aug 2, 2006 after 279 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- 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 K024307 (2003). 1 ancestor in all.
3 later devices descend 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)
- K024307: Dermosonic Non-Invasive Subdermal Therapy System, Sybaritic, Inc. (2003) Summary page 1.

## Most influential descendants
- K091615: Med Contour (2010), 2 descendants of its own
- K160075: Accent XL (2016), 0 descendants of its own
- K161502: MC1 Plus (2016), 0 descendants of its own

## Indications for use
The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for: a. Therapeutic Massager: i. Provides temporary relief of minor muscle aches and pains ii. Relieves muscle spasms iii. Temporarily improves local blood circulation iv. Temporarily reduces the appearance of cellulite b. Ultrasonic Diathermy: i. Relief of pain ii. Muscle spasms iii. Joint contractures iv. NOT for the treatment of malignancies

Source page: https://510kreport.com/device/K053041
Methodology: https://510kreport.com/methodology