510(k) · Cleared
Cleared300 PV Complete Electrotherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Empi · IPF Stimulator, Muscle, Powered
Cleared on Jun 18, 2002 as substantially equivalent to K951951 (Empi, 1996) and 2 other predicates after a 75-day review. Its family tree reaches back 1 generation to 1993. 48 later devices descend from it.
- Decided
- Jun 18, 2002
- Review
- 75 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931781 (1993). 3 ancestors in all. 48 later devices descend from it, 10 citing it directly.
- Root · 1 generation backK931781 Jace Tri-Stim DeviceJace Systems, Inc. · 1993
- This deviceK021100 300 PV Complete Electrotherapy SystemEmpi · 2002
- Descendant · cites it directly · 26 of its ownK093324 Empi ContinuumEmpi · 2010
- Descendant · 2 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · 3 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · 4 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · cites it directly · 9 of its ownK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K093324Empi ContinuumEmpi · 2010 · cites it directly26descendants
- K124016Empi PhoenixDjo, LLC · 2013 · 2 generations on25descendants
- K153704StriveDjo, LLC · 2016 · 3 generations on24descendants
- K170903Compex Wireless USADjo, LLC · 2017 · 4 generations on10descendants
- K110350Kneehab XPBio-Medical Research, Ltd. · 2011 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931781 | Jace Tri-Stim Device | Jace Systems, Inc. | 1993 | — |
| 0 (this device) | K021100 | 300 PV Complete Electrotherapy System | Empi | 2002 | — |
| +1 | K093324 | Empi Continuum | Empi | 2010 | — |
| +2 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +3 | K153704 | Strive | Djo, LLC | 2016 | — |
| +4 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +1 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | K951951 | Focus Model 795 UnitSummary page 1…ierferentiai Current Jtirnuiator, External Neuromuscular Functional Stimulator 3. PREDICATE DEVICES Empi Focus - K951951 JACE Tristim - K93 1871 RS Medical RS-4M+ - KO00 114 4. INTENDED USE The 300 PV is a multifunction electr… | 1996 |
| * | K931781 | Jace Tri-Stim Device Our reading of the summary gave K931871, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped in this product code whose FDA name shares the summary’s words. | 1993 |
| * | K000114 | RS-4M+Muscle Stimulator | 2000 |
What descends from it? (48)
See all 4810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093324 | Empi Continuum | 2010 | 26 |
| K110350 | Kneehab XP | 2011 | 9 |
| K141812 | Mygait Stimulation System | 2015 | 1 |
| K131917 | Neurodyn Compact, Neurodyn II | 2014 | 1 |
| K131629 | Neurodyn Multiwave, Aussie Sport | 2013 | 1 |
| K140467 | Flex-MT + | 2014 | 0 |
| K131923 | Neurodyn Portable Tens Nfes, Neurodyn Portable Tens | 2014 | 0 |
| K041920 | Infinity Plus Electrotherapy System | 2005 | 0 |
| K042057 | Infinity Electrotherapy System | 2004 | 0 |
| K023050 | Reliant BTL 5000 Puls Electrical Stimulation System, Reliant BTL 5000 Sono Ultrasound… | 2003 | 0 |
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?
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?
The 300 PV is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), interferential current stimulation (IFS) and functional electrical stimulation (FES). As a NMES device, the 300 PV is indicated for the following conditions: Retarding or preventing disuse atrophy Maintaining or increasing range of motion Re-educating muscles…
Read the full statement (170 words)
The 300 PV is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), interferential current stimulation (IFS) and functional electrical stimulation (FES).
As a NMES device, the 300 PV is indicated for the following conditions:
Retarding or preventing disuse atrophy
Maintaining or increasing range of motion
Re-educating muscles
Relaxation of muscle spasm
Increasing local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, the 300 PV is indicated for the following conditions:
Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
As an IFS device, the 300 PV is indicated for the following conditions:
Symptomatic relief of acute pain
Symptomatic relief and management of chronic pain
As a FES device, the 300 PV is indicated for the following condition:
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021100 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021100: 300 PV Complete Electrotherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021100
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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