# K153456: Megapulse III Shortwave Diathermy

- Pathway: 510(k) (Traditional)
- Applicant: Accelerated Care Plus
- Decided: Jun 14, 2016 after 196 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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: • Relieves pain • Increases the extensibility of collagen tissues • Decreases joint stiffness • Relieves muscle spasm • Increases local blood flow Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications: • Disorders of the musculoskeletal system o Muscle spasm o Joint stiffness o Joint contractures • Chronic inflammatory or infective conditions o Tenosynovitis o Bursitis o Synovitis o Chronic inflammatory pelvic diseases

Source page: https://510kreport.com/device/K153456
Methodology: https://510kreport.com/methodology