# K252963: BTL-899TT

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Jun 12, 2026 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: 4 generations back to K861248 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161862: ThermoPro, Zimmer Medizinsysteme GmbH (2016) Summary page 6.

## Indications for use
BTL-899TT is indicated to be used in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases. Generally accepted indications for use: o Pain Relief o Contractures o Reduce Muscle Spasm o Localized increase Blood Flow o Chronic Inflammatory Conditions o Bursitis o Decrease Joint Stiffness o Tenosynovitis o Synovitis o Chronic Inflammatory Pelvic Disease

Source page: https://510kreport.com/device/K252963
Methodology: https://510kreport.com/methodology