# K241395: Active System; Avenue8

- Pathway: 510(k) (Traditional)
- Applicant: Caerus Corporation
- Decided: Dec 18, 2024 after 216 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
Longest line of descent: 4 generations back to K903675 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121702: Orthocor Active Device Orthocor General Use Active Device, Orthocor Medical (2013) Summary page 5.
- K092044: Orthocor Knee System, Median, Large, X-Large, Orthocor Medical (2009) Summary page 5.
- K202337: Pulsed electromagnetic field wrap, Hi-Dow International, Inc. (2020) Summary page 5.

## Indications for use
The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

Source page: https://510kreport.com/device/K241395
Methodology: https://510kreport.com/methodology