# K083433: Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601

- Pathway: 510(k) (Traditional)
- Applicant: Chattanooga Group
- Decided: Mar 18, 2009 after 118 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861248 (1986). 5 ancestors in all.
61 later devices descend from it; 4 cite it directly.
0 of 67 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 3.
- K030382: Selitherm, Model C100, Selicor, Inc. (2003) Summary page 3.
- K022458: Auto*Therm 395, Model ME 395, Mettler Electronics Corp. (2002) Summary page 3.
- K973732: Megapulse II, Pti (1998) Summary page 3.

## Most influential descendants
- 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
- K153568: InMode Plus System (2016), 18 descendants of its own

## Recalls of this device
- Aug 21, 2015 · Class II · Z-0121-2016: Overheating and burning of the wire insulation inside the applicator.

## Indications for use
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases. Generally accepted indications for use: Pain Relief Reduce Muscle Spasm Decrease Joint Stiffness Contractures Iincrease Blood Flow Chronic Inflammatory Conditions Bursitis Tenosynovitis Synovitis Chronic Inflammatory Pelvic Disease

Source page: https://510kreport.com/device/K083433
Methodology: https://510kreport.com/methodology