# K023050: Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound System, Reliant BTL 5000 Combi

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Feb 14, 2003 after 154 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: 2 generations back to K923076 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982317: Vectra Combo, Chattanooga Group, Inc. (1999) Summary page 1.
- K982324: Vectra Pro Models 2 and 4, Chattanooga Group, Inc. (1999) Summary page 1.
- K935728: Dynatron 150, Dynatronics Corp. (1994) Summary page 1.
- K001166: Ultra V Therapeutic Ultrasound, Excel Tech., Ltd. (2000) Summary page 2.
- K021100: 300 PV Complete Electrotherapy System, Empi (2002)

## Indications for use
The Reliant BTL 5000 Puls Electrical Stimulation System and the BTL 5000 Combi Combination Electrical Stimulation & Ultrasound System (and the delivery accessories that are used with them) are indicated for use in the medical specialties of physical medicine, general and plastic surgery and neurology for medical purposes/applications requiring: Electrical Stimulation for Muscle & Soft Tissue StimulatiodPain Management: TENS, Russian, High Voltage Therapy Modes Treatment and relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate postoperative/post-surgical stimulation of calf muscles to prevent venous thrombosis TENS, Microcurrent, Interferential and Premodulated Modes Symptomatic relief of chronic and/or intractable pain Management of acute pain associated with post-traumatic or post-operative conditions The Reliant BTL 5000 Sono Ultrasound System and the BTL 5000 Combi Combination Electrical Stimulation & Ultrasound System (and the delivery accessories that are used with them) are indicated for use in the medical specialty of physical medicine for medical purposes/applications requiring: Ultrasound for Deep Heat/Pain Management: Application of therapeutic deep heat for the treatment of selected chronic and subchronic medical conditions such as: Relief of pain, muscle spasms and joint contractures Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis Bursitis with slight calcification Myositis Soft tissue injuries Shortened tendons due to past injuries and scar tissues Relief of chronic and subchronic pain and joint contractures resulting from: Capsular tightness Capsular scarring The combination ultrasound and electrotherapy modes deliver deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Only one electrotherapy mode (TENS, High Voltage, Interferential or Premodulated) can be utilized at a time in conjunction with the ultrasound mode.

Source page: https://510kreport.com/device/K023050
Methodology: https://510kreport.com/methodology