# K161502: MC1 Plus

- Pathway: 510(k) (Special)
- Applicant: General Project S.R.L.
- Decided: Aug 16, 2016 after 76 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: 3 generations back to K024307 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091615: Med Contour, General Project S.R.L. (2010) Summary page 4.

## Indications for use
The MC1 Plus 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/K161502
Methodology: https://510kreport.com/methodology