# K973732: Megapulse II

- Pathway: 510(k) (Traditional)
- Applicant: Pti
- Decided: Jan 23, 1998 after 115 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
No predicates in its family tree.
63 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects: 1. Increases the extensibility of collagen tissues Decreases joint stiffness Relieves pain Relieves muscle spasm Increases blood flow The Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications: 1. Disorders of the musculoskeletal system: muscle spasm joint stiffness, contractures 2. Chronic inflammatory or infective conditions: tenosynovitis, bursitis, synovitis chronic inflammatory pelvic diseases

Source page: https://510kreport.com/device/K973732
Methodology: https://510kreport.com/methodology