# K102524: Futura

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Oliver Wenker, M.D., M.B.A.
- Decided: Nov 3, 2011 after 427 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926410 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926410: Ultratone 8+ & 20, Bowater Research, Inc. (1993) Summary page 1.
- K050410: Hes Ultrasonic Therapy Appliance, Models HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ), Hwang Sun Enterprise Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K233099: Gladiator (2024), 0 descendants of its own

## Indications for use
MUSCLE STIMULATOR INDICATIONS FOR USE: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining or increasing range of motion Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. ULTRASOUND INDICATIONS FOR USE: Application of deep heat for: 1. Temporary relief of minor pain 2. Muscle spasm relief 3. Joint contracture relief Not for treatment of malignancies. Not for use on the face.

Source page: https://510kreport.com/device/K102524
Methodology: https://510kreport.com/methodology