# K243112: Curapuls 670

- Pathway: 510(k) (Traditional)
- Applicant: Enraf-Nonius, B.V.
- Decided: Jun 25, 2025 after 268 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
Longest line of descent: 5 generations back to K861248 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182363: BTL-703, BTL Industries, Inc. (2019) Summary page 5.

## Indications for use
The Curapuls 670 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.

Source page: https://510kreport.com/device/K243112
Methodology: https://510kreport.com/methodology