# K162240: ProMedTek Model C1400 Shortwave Diathermy Device

- Pathway: 510(k) (Traditional)
- Applicant: Promedtek, Inc.
- Decided: Nov 17, 2016 after 100 days
- Product code: IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5290
- 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 K042554 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042554: Auto Therm 390, Model ME 390, Mettler Electronics Corp. (2004) Summary page 4.

## Indications for use
The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as: 1. Relieving pain 2. Reducing muscle spasm 3. Increasing range of motion of contracted joints using heat and stretch techniques 4. Increasing blood flow to tissues in the treatment area

Source page: https://510kreport.com/device/K162240
Methodology: https://510kreport.com/methodology