# K120093: BTL Elite

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Oct 5, 2012 after 267 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: 3 generations back to K861248 (1986). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083433: Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601, Chattanooga Group (2009) Summary page 2.
- K022458: Auto*Therm 395, Model ME 395, Mettler Electronics Corp. (2002) Summary page 2.

## Most influential descendants
- K182363: BTL-703 (2019), 1 descendant of its own
- K243112: Curapuls 670 (2025), 0 descendants of its own

## Indications for use
Indications for use in applying therapeutic deep heat In body tissues for the treatment of 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/K120093
Methodology: https://510kreport.com/methodology