# K091615: Med Contour

- Pathway: 510(k) (Traditional)
- Applicant: General Project S.R.L.
- Decided: May 6, 2010 after 337 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: 2 generations back to K024307 (2003). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053041: Med Sculpt, General Project S.R.L. (2006) Summary page 1.
- K024307: Dermosonic Non-Invasive Subdermal Therapy System, Sybaritic, Inc. (2003) Summary page 1.
- K982830: Forte, Models CPS 400 Combo, CPS 200 Combo, Chattanooga Group, Inc. (1998) Summary page 1.
- K883893: Omnisound (TM) 3000, Physio Technology, Inc. (1988) Summary page 1.

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

## Indications for use
The MCi is indicated for: a) Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains; 2. Relieves muscle spasms, 3. Temporarily improves local blood circulation; 4. Temporarily reduces the appearance of cellulite. b) Ultrasonic Diathermy: 1. Relief of pain; 2. Muscle spasms; 3. Joint contractures; 4. NOT for the treatment of malignancies.

Source page: https://510kreport.com/device/K091615
Methodology: https://510kreport.com/methodology