# K121123: Biofusionary Bebe

- Pathway: 510(k) (Traditional)
- Applicant: Rocky Mountain Biosystems, Inc.
- Decided: Mar 10, 2014 after 696 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: 3 generations back to K861248 (1986). 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)
- K083433: Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601, Chattanooga Group (2009) Summary page 1.

## Indications for use
The Bioflsionary Bebe System is indicated to be used to generate deep heat within body tissues for the treatment of medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Source page: https://510kreport.com/device/K121123
Methodology: https://510kreport.com/methodology