# K022458: Auto*Therm 395, Model ME 395

- Pathway: 510(k) (Abbreviated)
- Applicant: Mettler Electronics Corp.
- Decided: Sep 26, 2002 after 62 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 K861248 (1986). 1 ancestor in all.
62 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861248: Curapuls 419 Diathermy Unit, Henley Intl. (1986) Summary page 1.

## Most influential descendants
- K083433: Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 (2009), 61 descendants of its own
- K090221: Reaction System (2009), 54 descendants of its own
- K133837: Viora V-Total (2014), 33 descendants of its own
- K142093: V20 System (2014), 32 descendants of its own
- K150035: V10 system (2015), 31 descendants of its own

## Indications for use
Shortwave diathermy delivers energy in the radio band of 27.12 MIiz 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; and 4. Increasing blood flow to tissues in the treatment area.

Source page: https://510kreport.com/device/K022458
Methodology: https://510kreport.com/methodology