FDA product code · Physical Medicine
IPFStimulator, Muscle, Powered
Product code IPF covers Stimulator, Muscle, Powered, a Class II device regulated under 21 CFR 890.5850. FDA has cleared 548 devices in this code, 4 of them in the last 12 months. Median review time across the 548 most recent decisions is 108 days. openFDA lists 7 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 890.5850
- Review panel
- Physical Medicine
- Clearances
- 548
What is happening in IPF right now?
IPF (Stimulator, Muscle, Powered) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Mohammadali Nezakati and Motion Informatics ltd (K252816, K260142, K251083). The code is crowded, scoring 86 of 100 — 303 companies hold a clearance here and 4 arrived in the last 12 months (IPF:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252816, K260142, K251083 |
| Crowding | Context | IPF:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in IPF?
FDA has cleared 548 devices under product code IPF since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | |
| K251083 | Compact II | Enraf-Nonius, B.V. | |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | |
| K241488 | TrainFES Advance | Trainfes | |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | |
| K240234 | BTL-899MS | BTL Industries, Inc. | |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC |
How long does FDA review take for IPF?
The median FDA review time for IPF is 108 days, measured across the 548 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in IPF?
openFDA lists 7 recall records against product code IPF. A recall record covers one firm's corrective action and may span many device lots.
Z-0506-2024Open, ClassifiedLiberty Medical Solutions, LLC
The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
Z-1137-2012TerminatedIon Genius, Inc.
Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
Z-1138-2012TerminatedIon Genius, Inc.
Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
Z-1141-2012TerminatedIon Genius, Inc.
Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA
Z-2880-2011TerminatedeSwallow USA LLC
It was discovered that the firm was distributing medical devices without FDA approval.
Showing the 5 most recently initiated of 7. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for IPF?
MAUDE holds 25 adverse-event reports naming product code IPF, 9 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in IPF unusual?
IPF does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
15 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered IPF in the last year?
3 companies filed in IPF for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Mohammadali Nezakati | K252816 | |
| Motion Informatics ltd. | K260142 | |
| Enraf-Nonius, B.V. | K251083 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in IPF?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in IPF?
Across the 548 most recent decisions, these applicants filed most often in IPF.
| Applicant | Recent clearances |
|---|---|
| Rich-Mar Corp. | 17 |
| Bloomex International, Inc. | 14 |
| Chattanooga Group, Inc. | 11 |
| Maximum Performance Technologies, Mpts, Inc. | 11 |
| Mettler Electronics Corp. | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in IPF file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Chattanooga Group, Inc. | 14 | 2 |
| Mettler Electronics Corporation | 13 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch IPF
Get an email the morning anything changes in IPF — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Physical Medicine
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.