Product code IPF— Physical Medicine
POWERED MUSCLE STIMULATOR
- Classification name
- Stimulator, Muscle, Powered
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Total cleared
- 548
- First cleared
- Most recent
Market context for product code IPF
FDA has cleared devices under product code IPF between 1976 and 2026, filed by 311 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code IPF
Recent clearances under product code IPF
1–100 of 548- K253542 — Apollo Quattro (APQ-10M)
- K252816 — High Tone Power therapy (HiToP) (Model: HiToP PNP)
- K260142 — StimelMD (SSMD) system
- K251083 — Compact II
- K241433 — EVE Synergy (EVE-20M)
- K241488 — TrainFES Advance
- K240348 — Quantum Mitohormesis (QMT) (M2101)
- K240992 — eMVFit (MVF-10M)
- K240234 — BTL-899MS
- K233098 — MYOTouch Muscle Stimulator
- K232786 — Stimulation System (PA series, PR series, S series and Q series)
- K233926 — accufit
- K233485 — M-Wave
- K232937 — BTL-899M
- K230701 — Stim2Go
- K231440 — Combo Electrotherapy Device
- K223027 — NeuroTrigger Basic (NTB)
- K223802 — accufit
- K221274 — StarFormer, TightWave
- K230167 — BACK 4
- K232334 — DEKA SIMON
- K213655 — HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
- K221958 — Flex-MI
- K222201 — Biological Feedback and Stimulation System
- K220994 — Shoulder PacemakerTM
- K213197 — MyOnyx System
- K220738 — Motive Knee Wrap
- K220327 — geko W-3
- K213043 — Levator Elite (Model LE9011)
- K212832 — TimeWaver Frequency
- K212762 — geko W-2
- K192746 — MyoWorx TM20
- K210002 — STELLA BIO
- K210674 — Shoulder Pacemaker
- K210938 — PowerDot PD-01MT2 Muscle Stimulator
- K211094 — Nerve and Muscle Stimulator
- K210604 — Intellihab System
- K210979 — Prelivia
- K210572 — Neurodyn V2.0, Neurodyn Aussie V2.0
- K202031 — Talent-Pro Electromagnetic Stimulator
- K203710 — Storz Medical MAGNETOLITH Muscle Stimulator
- K201285 — InMode Evolve System with the Tone Applicator
- K210269 — PowerDot PD-01MT2 Muscle Stimulator
- K203488 — emField
- K202648 — Biofeedback Nerve and Muscle Stimulator
- K202079 — Physiq
- K202490 — Avid CT2
- K200088 — g.Estim FES
- K201290 — Medline DeNovo 4Pro Electrical Stimulation Device
- K201958 — ETD Family of Electrotherapy Devices
- K193275 — Nerve and Muscle Stimulator
- K193045 — geko W-2
- K183074 — TENS and EMS Stimulator, TENS Stimulator
- K192733 — RelieforMe TENS/EMS Device Model UPK-GE01
- K192249 — InMode System with Tone Applicator
- K191113 — geko T-2 and geko T-3 Neuromuscular Stimulators
- K182163 — Shear Stress Therapeutics SST 3000
- K181759 — PowerDot PD-01MT
- K181688 — R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
- K181059 — geko T-3 Neuromuscular Stimulator
- K172381 — Digitimer DS7AP Constant Current Stimulator
- K180082 — geko T-2 and geko Plus R-2
- K171978 — Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
- K171071 — StimSox(TM) System
- K171387 — EMS100 Tri-Wave Combination Stimulator
- K163125 — geko T-2 and geko Plus R-2 Neuromuscular Stimulators
- K162987 — FA100 SCCD (Sequential Continuous Contraction Device)
- K160614 — Xcite Clinical Station
- K163067 — CyMedica e-vive System; CY-1000
- K160992 — HPM-6000
- K151922 — StimSox(TM) System
- K153696 — Chattanooga Revolution Wireless
- K160299 — geko(TM) Plus R-2 Neuromuscular Stimulator
- K153224 — VitalStim(R) Plus Electrotherapy System
- K152677 — geko T-2 Neuromuscular Stimulator
- K150742 — Muscle Stimulation System 110
- K150413 — QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
- K140467 — FLEX-MT +
- K133638 — GEKO
- K131917 — NEURODYN COMPACT, NEURODYN II
- K132284 — VECTRA NEO CLINICAL THERAPY SYSTEM
- K130052 — TONE-A-MATIC
- K130691 — ELECTROTHERAPY DEVICE (COMBO UNIT)
- K131629 — NEURODYN MULTIWAVE, AUSSIE SPORT
- K131222 — AMPCARE ESP THERAPY SYSTEM
- K132137 — MULTISTIM
- K130424 — STIMEL-03
- K123354 — REVITIVE IX
- K124016 — EMPI PHOENIX
- K123642 — MUSCLE STIMULATION SYSTEM
- K120922 — GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
- K113010 — FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
- K113017 — SYS*STIM 240
- K112148 — POWERED MUSCLE STIMULATOR
- K112348 — RS-4I MUSCLE STIMULATOR
- K111279 — NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
- K103738 — H-WAVE
- K100862 — BODYFLOW P2CH
- K092202 — ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT
- K102202 — GS 3000
Data sourced from openFDA. This site is unofficial and independent of the FDA.