510(k) · Cleared
ClearedReliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound System, Reliant BTL 5000 Combi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliant Technologies, Inc. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Feb 14, 2003 as substantially equivalent to K982317 (Chattanooga Group, Inc., 1999) and 4 other predicates after a 154-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Feb 14, 2003
- Review
- 154 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K923076 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923076 | Ultra SX | Excel Tech., Ltd. | 1993 | — |
| −1 | K001166 | Ultra V Therapeutic Ultrasound | Excel Tech., Ltd. | 2000 | — |
| 0 (this device) | K023050 | Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono… | Reliant Technologies, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IMG device
- #1 K244041 Ultrasound Therapy Workstation (XMS-UET2)score 10.7 · 3 generations · no Class I recall
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982317 | Vectra ComboSummary page 1…ary Classification Name: Ultrasound and Muscle Stimulator (and Accessories) 111. Predicate Devices 0 Chattanooga Group, Inc. Vectra 2C and Vectra 4C (K9823 17); 0 Chattanooga Group, Inc. Vectra Pro 2 and Vectra Pro 4 (K982324); 0 Dynatronics Corporation Dynatron 150… | 1999 |
| * | K982324 | Vectra Pro Models 2 and 4Summary page 1…111. Predicate Devices 0 Chattanooga Group, Inc. Vectra 2C and Vectra 4C (K9823 17); 0 Chattanooga Group, Inc. Vectra Pro 2 and Vectra Pro 4 (K982324); 0 Dynatronics Corporation Dynatron 150 Plus Ultrasound (K935728); 0 Excel Tech XL Tek Ultra VM Ultrasound… | 1999 |
| * | K935728 | Dynatron 150Summary page 1…nd Vectra 4C (K9823 17); 0 Chattanooga Group, Inc. Vectra Pro 2 and Vectra Pro 4 (K982324); 0 Dynatronics Corporation Dynatron 150 Plus Ultrasound (K935728); 0 Excel Tech XL Tek Ultra VM Ultrasound (KO0 1 166); and 0 Empi 300 PV Complete Electrotherapy System (KO… | 1994 |
| * | K001166 | Ultra V Therapeutic UltrasoundSummary page 2…Vectra Pro 2 and Vectra Pro 4 (K982324), the Dynatronics Corporation Dynatron 150 Plus Ultrasound (K935728) , the Excel Tech XL Tek Ultra VM Ultrasound (K001166), and the Empi 300 PV Complete Electrotherapy (KO21 100) systems. VII. Safety and Effectiveness Information V… | 2000 |
| * | K021100 | 300 PV Complete Electrotherapy System | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K982317.
How does its category compare?
All IMG devicesIMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMG
226in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMG
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMG
9in 2025
MAUDE reports naming product code IMG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 110 | 0 | 0 |
| 2008 | 0 | — | 2 | 37 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 3 | 226 | 0 | 21 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (293 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023050: Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound System, Reliant BTL 5000 Combi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023050
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026