510(k) · Cleared
ClearedMedstar 100 Interferential Stimlator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mednet Services, Inc. · LIH Interferential Current Therapy
Cleared on Nov 16, 2001 as substantially equivalent to K924961 (Hmp 4000, Inc., 1993) after a 63-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 16, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924961 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK924961 HMP 4000 Interferential StimulatorHmp 4000, Inc. · 1993
- This deviceK013082 Medstar 100 Interferential StimlatorMednet Services, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924961 | HMP 4000 Interferential Stimulator | Hmp 4000, Inc. | 1993 | — |
| 0 (this device) | K013082 | Medstar 100 Interferential Stimlator | Mednet Services, Inc. | 2001 | — |
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 LIH? 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 LIH device
- #1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K924961 | HMP 4000 Interferential StimulatorSummary page 1…rferential Stimulator COMMON NAME: Interferential Stimulator (LIH) CLASSIFICATION: Class II PRODUCT CODE: LIH PREDICATE DEVICE (S): HMP 4000 Interferential Stimulator (K924961) DEVICE DESCRIPTION: The MEDSTAR 100 is a DC battery powered device that generates small pulses of electric current. These small… | 1993 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K924961.
How does its category compare?
All LIH devicesLIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIH
Too few LIH 510(k)s in any year since 2007 to give a median.
Recalls per year · LIH
No recall names LIH since 2007.
Adverse event reports per year · LIH
1in 2025
MAUDE reports naming product code LIH, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MEDSTAR 100 Interferential Stimulator should only be used under the supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
e symptomatic relief and management of chronic pain and/or
e an adjunctive treatment in the management of post surgical and posttraumatic acute pain.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013082: Medstar 100 Interferential Stimlator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013082
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026