510(k) · Cleared
ClearedBTL-4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Cleared on Nov 13, 2015 as substantially equivalent to K031077 (Chattanooga Group, 2003) and 1 other predicate after a 275-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Nov 13, 2015
- Review
- 275 days
- Class
- Class II
- Product code
- IMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031077 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK031077 Vectra Epr System and Intelect Epr SystemChattanooga Group · 2003 · Recalled
- This deviceK150353 BTL-4000BTL Industries, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031077 | Vectra Epr System and Intelect Epr System | Chattanooga Group | 2003 | 17 |
| 0 (this device) | K150353 | BTL-4000 | BTL Industries, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K031077 | Vectra Epr System and Intelect Epr SystemSummary page 6…ucts that are already cleared for USA distribution under the following 510(k) Premarket Notification numbers: Vectra Genisys – Chattanooga Medical Supply, Inc. (K031077) Vectra Genisys Laser Module – Chattanooga Medical Supply, Inc. (K040662) Product Description BTL-4000 is a professional… | 2003 |
| * | K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…Summary page 6…market Notification numbers: Vectra Genisys – Chattanooga Medical Supply, Inc. (K031077) Vectra Genisys Laser Module – Chattanooga Medical Supply, Inc. (K040662) Product Description BTL-4000 is a professional physiotherapy device. Depending on the required configuration, the device can co… | 2004 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 8 other devices also cite its predicate K031077.
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. 2015, this device’s year, is highlighted.
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?
VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for relaxation of muscle spasms; prevention or retardation of disuse atrophy; increase of local blood circulation; muscle reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic…
Read the full statement (240 words)
VMS, VMS Burst, Russian, Monophasic Hi-Volt (NMES). Interferential and Premodulated (IFS) are indicated for
relaxation of muscle spasms; prevention or retardation of disuse atrophy; increase of local blood circulation; muscle
reeducation; maintaining or increasing range of motion and immediate postsurgical stimulation of calf muscles to prevent
venous thrombosis.
Microcurrent, Interferential, Premodulated (IFS), VMS, VMS Burst, Asymmetrical Biphasic (TENS) and Symmetrical
Biphasic (TENS) are indicated for symptomatic relief and management of chronic, intractable pain; post-traumatic acute
pain and post-surgical acute pain.
FES is indicated for stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the
foot and thus improve the patient's gait.
DC Continuous Mode is indicated for relaxation of muscle spasm.
Ultrasound module is indicated for an application of therapeutic deep heat for the treatment of selected sub-chronic and
chronic 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 sub-chronic, chronic pain and joint contractures
resulting from: capsular tightness, capsular scaring.
Laser module is indicated for topical heating for: temporary increase of local blood circulation; temporary relief of minor
muscle and joint aches, pains, and stiffness; relaxation of muscles; temporary relief of muscle spasms and temporary relief
of minor pain and stiffness associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150353: BTL-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150353
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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