# K202337: Pulsed electromagnetic field wrap

- Pathway: 510(k) (Traditional)
- Applicant: Hi-Dow International, Inc.
- Decided: Dec 15, 2020 after 120 days
- Product code: ILX (Diathermy, Shortwave, For Use Other Than 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K241395: Active System; Avenue8 (2024), 0 descendants of its own

## Indications for use
The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It is also indicated for the temporary relief of minor muscle and joint aches and pain associated with overexertion, strains, sprains and arthritis.

Source page: https://510kreport.com/device/K202337
Methodology: https://510kreport.com/methodology