510(k) · Cleared
ClearedProduct Line-Combo Stimulator/Sequential Stimulator, Model IF-5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johari Digital Healthcare, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 20, 2002 as substantially equivalent to K993229 (Johari Electro-Tech Co., 2001) after a 14-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Dec 20, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964028 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K993229 | Analgesic Pulser, Model AP-439Summary page 2…21 CFR Section 882-5890). LEGALLY MARKETED DEVICE Analgesic Pulsar AP-439 : Nerve & Interferential Stimulator 5 1O(k) Number K993229 M ai1IIfact u rer JOHARI DIGITAL HEALTHCARE LTD. Address EC-1-2-3, ELECTRONIC COMPLEX… | 2001 |
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 5 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
Combo Stimulator IF-5000 provides combination of desired stimulating currents, which can be chosen by clinicians for the following treatment therapies: INTENDED USE (A) Interferential Current Stimulation is indicated for: 1. Symptomatic relief and management of chronic, intractable pain: 2. Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions. (B) Electrical Muscle Stimulation (EMS or Russian) is indicated…
Read the full statement (99 words)
Combo Stimulator IF-5000 provides combination of desired stimulating currents, which can be chosen by clinicians for the following treatment therapies:
INTENDED USE
(A) Interferential Current Stimulation is indicated for:
1. Symptomatic relief and management of chronic, intractable pain:
2. Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions.
(B) Electrical Muscle Stimulation (EMS or Russian) is indicated for:
1. Relaxation of Muscle spasm.
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.
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/K024036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024036: Product Line-Combo Stimulator/Sequential Stimulator, Model IF-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024036
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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