Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- K231053Unicare (K-UNICARE-USA)2Cleared 510(K)
- K223151Nu-beca Transcutaneous Electrical Nerve Stimulation2Cleared 510(K)
- K230443TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)2Cleared 510(K)
- K223308HEATING TENS/EMS, FT-810R2Cleared 510(K)
- K222870Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-40392Cleared 510(K)
- K223825Tens & Ems Device2Cleared 510(K)
- K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)2Cleared 510(K)
- K230829TENS7000 Rechargeable (Model:TENS7000 Rechargeable)2Cleared 510(K)
- K230164TENS and EMS Stimulation (OTC)2Cleared 510(K)
- K230174TENS and EMS Stimulation (OTC)2Cleared 510(K)
- K230174TENS and EMS Stimulation (OTC)2Cleared 510(K)
- K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)2Cleared 510(K)
- K222488Everyway Analog OTC TENS2Cleared 510(K)
- K221992Electronic Pulse Stimulator2Cleared 510(K)
- K221092Transcutaneous Electrical Nerve Stimulator Model: ST-3042Cleared 510(K)
- K220997Wireless TENS/EMS, Bruno, Aela2Cleared 510(K)
- K220998Transcutaneous Electrical Nerve Stimulator, Model: KTR-4052Cleared 510(K)
- K220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)2Cleared 510(K)
- K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)2Cleared 510(K)
- K220573Noodle2Cleared 510(K)
- K221384Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-22Cleared 510(K)
- K213788TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)2Cleared 510(K)
- K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)2Cleared 510(K)
- K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)2Cleared 510(K)
- K212377Transcutaneous Electrical Applicator (TEA), Model SNM-FDC012Cleared 510(K)
- K220005TENS & PMS Unit2Cleared 510(K)
- K212184TENS and EMS Stimulation (OTC)2Cleared 510(K)
- K213741TENS & EMS DEVICE (Model: FM-B2403A)2Cleared 510(K)
- K213835TENS & EMS Device2Cleared 510(K)
- K213091Well-Life TENS/EMS/Heating Stimulator2Cleared 510(K)
- K220150TENS & PMS (Model: SM9126)2Cleared 510(K)
- K211263Intrelief2Cleared 510(K)
- K212285Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)2Cleared 510(K)
- K210223Transcutaneous Electrical Nerve Stimulator2Cleared 510(K)
- K212918Heat StimPlus2Cleared 510(K)
- K212989Low-frequency Stimulator (Model: AST-645, AST-646)2Cleared 510(K)
- K202671DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)2Cleared 510(K)
- K211403HIVOX OTC Electrical Stimulator, FT610-B2Cleared 510(K)
- K200558Smart Neck Stimulator2Cleared 510(K)
- K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)2Cleared 510(K)
- K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H2Cleared 510(K)
- K200694Perfect EMS2Cleared 510(K)
- K202866TENS & EMS Device2Cleared 510(K)
- K200177Low-frequency Multi-function physiotherapy instrument2Cleared 510(K)
- K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-22Cleared 510(K)
- K202849Everyway Analog OTC TENS, model N103A/N3022Cleared 510(K)
- K202470Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-63002Cleared 510(K)
- K202317Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-8062Cleared 510(K)
- K201335Li-Battery powered OTC TENS/EMS Combination Stimulator2Cleared 510(K)
- K200237Transcutaneous Electronic Nerve Stimulator2Cleared 510(K)
- K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)2Cleared 510(K)
- K193655MSLS6QF TENS/PMS Device2Cleared 510(K)
- K200838Tyece OTC TENS Model2Cleared 510(K)
- K200561StimPlus Patch, StimPlus Patch, StimPlus Patch2Cleared 510(K)
- K200354Electronic stimulator2Cleared 510(K)
- K200727TENS and Muscle Stimulator2Cleared 510(K)
- K192201Electrical Stimulator System2Cleared 510(K)
- K183110LIVIA2Cleared 510(K)
- K190783Health Expert Electronic Stimulator (model: AST-3000L)2Cleared 510(K)
- K192589Everyway OTC TENS/EMS Combination2Cleared 510(K)
- K190673Health Expert Electronic Stimulator2Cleared 510(K)
- K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)2Cleared 510(K)
- K191075Healy2Cleared 510(K)
- K192087Combo Electrotherapy Device2Cleared 510(K)
- K183674Electronic Pulse Stimulator2Cleared 510(K)
- K182136Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)2Cleared 510(K)
- K182671Medi-Direct TENS Pen2Cleared 510(K)
- K183215Focus TENS Therapy, Model PM710-M/-L2Cleared 510(K)
- K190988GIM-STIM OTC TENS/EMS System2Cleared 510(K)
- K182871Mini TENS Therapy Device2Cleared 510(K)
- K183288Transcutaneous Electrical Nerve Stimulator2Cleared 510(K)
- K191151JKH Stimulator Plus2Cleared 510(K)
- K190115MHD TENS2Cleared 510(K)
- K182108Portable Electro-Stimulation Therapy Device2Cleared 510(K)
- K190347HIVOX OTC Electrical Stimulator2Cleared 510(K)
- K182203JKH Stimulator Plus2Cleared 510(K)
- K182267PAT (Pain Alleviation Technologies)2Cleared 510(K)
- K182120Maxpower Relief2Cleared 510(K)
- K172897Neck Care Therapy, Model: SYK 509B2Cleared 510(K)
- K172837Low-frequency Multi-function physiotherapy instrument2Cleared 510(K)
- K182581PlayMakar Sport Muscle Stimulator, Model PRO-5002Cleared 510(K)
- K181992Heat Pain Pro2Cleared 510(K)
- K182767V2 OTC Pain Relief TENS2Cleared 510(K)
- K182753A6 OTC Pain Relief TENS2Cleared 510(K)
- K181707Everyway Wireless TENS & EMS Unit2Cleared 510(K)
- K181102ThermaCare Quick Therapy TENS2Cleared 510(K)
- K172834Dual output digital therapy massager2Cleared 510(K)
- K181849iStim S2 OTC Pain Relief TENS2Cleared 510(K)
- K172971BMLS16-12Cleared 510(K)
- K180331Wireless Pain Relieve Device2Cleared 510(K)
- K180956Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator2Cleared 510(K)
- K181207Balego TENS Digital Edition with Accessories for Pain Relief (OTC)2Cleared 510(K)
- K172919EV-804 OTC Pain Relief TENS2Cleared 510(K)
- K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)2Cleared 510(K)
- K173462Wireless Pain Relieve Device Model: LT5018C2Cleared 510(K)
- K171803HIVOX OTC Electrical Stimulator2Cleared 510(K)
- K172451Dr.MUSIC 3s2Cleared 510(K)
- K171026Mytens Model: BW-TSX2Cleared 510(K)
- K172079Avail2Cleared 510(K)
- K172809OTC Combo TENS/EMS System2Cleared 510(K)
- K171599WiTouch Pro, WiTouch, Neubac2Cleared 510(K)
- K163611Pain Therapy Device2Cleared 510(K)
- K163166EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only2Cleared 510(K)
- K163393Hi-Dow Wireless TENS/EMS System (Model HD-SN)2Cleared 510(K)
- K163153Livia2Cleared 510(K)
- K170659IQ Technologies2Cleared 510(K)
- K162392Avazzia2Cleared 510(K)
- K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-2032Cleared 510(K)
- K170145Digital TENS Unit2Cleared 510(K)
- K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K132Cleared 510(K)
- K162479Smart Pain Reliever, Model LT50192Cleared 510(K)
- K162630CP Relief Wand-OTC2Cleared 510(K)
- K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A2Cleared 510(K)
- K160508Electronic Pulse Stimulator2Cleared 510(K)
- K161537OTC TENS Device, Model PTS-IV2Cleared 510(K)
- K151995Painmaster MCT Patch2Cleared 510(K)
- K160255HBOTC Muscle and Nerve Stimulator2Cleared 510(K)
- K160893HANAROCare ReJu2Cleared 510(K)
- K160115Heat Pain Pro2Cleared 510(K)
- K160052CUR Model 12Cleared 510(K)
- K153520Electronic Pulse Stimulator2Cleared 510(K)
- K150277Pain Therapy System, Model PTS-II2Cleared 510(K)
- K152374LL TENS 160A, LL TENS 160B2Cleared 510(K)
- K152954Quell2Cleared 510(K)
- K1521282-in-1 Abdominal Muscle Training & Back Pain Relief System2Cleared 510(K)
- K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)2Cleared 510(K)
- K151279Counter OTC TENS Device, Model CSD-737Z2Cleared 510(K)
- K151034PainKARE2Cleared 510(K)
- K150386Tyece OTC TENS Device2Cleared 510(K)
- K150308Palm TENS2Cleared 510(K)
- K151479EV-820 OTC Pain Relief TENS2Cleared 510(K)
- K150043Transcutaneous Electrical Nerve Stimulators (TENS)2Cleared 510(K)
- K151035PulseRelief2Cleared 510(K)
- K143268TENS AND POWERED MUSCLE STIMULATOR2Cleared 510(K)
- K150995Electronic Pulse Stimulator2Cleared 510(K)
- K143430SmartTENS2Cleared 510(K)
- K150681GEMORE OTC TENS2Cleared 510(K)
- K133789DOLPHIN NEUROSTIM OTC2Cleared 510(K)
- K142686StimPad OTC2Cleared 510(K)
- K141978MAXPOWER RELIEF2Cleared 510(K)
- K1335025000Z FIREFLY SYSTEM2Cleared 510(K)
- K141299OTC COMBO TENS/EMS SYSTEM2Cleared 510(K)
- K133929HEALTH EXPERT ELCTRONIC STIMULATOR2Cleared 510(K)
- K141260ELECTRONIC PULSE STIMULATOR2Cleared 510(K)
- K140168EASYSTIM TN28_OTC2Cleared 510(K)
- K133979TENS2Cleared 510(K)
- K131290IQ TECHNOLOGIES2Cleared 510(K)
- K140333ASCEND2Cleared 510(K)
- K140650HIVOX ELECTRIC STIMULATOR OTC TENS2Cleared 510(K)
- K132993COUNTER OTC TENS DEVICE2Cleared 510(K)
- K132563PINOOK STIMULATOR2Cleared 510(K)
- K131956QUICK RELAX PRO2Cleared 510(K)
- K133723OTC PATCH2Cleared 510(K)
- K131910MPP2Cleared 510(K)
- K131933ELECTRONIC PULSE MASSAGER2Cleared 510(K)
- K131921ELECTRONIC PULSE STIMULATOR2Cleared 510(K)
- K122410I RUNE (I-200L)2Cleared 510(K)
- K130150TCM MASSAGER2Cleared 510(K)
- K130802OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)2Cleared 510(K)
- K123866TANYX2Cleared 510(K)
- K131159SMARTRELIEF2Cleared 510(K)
- K124055T1040 AKA AURAWAVE2Cleared 510(K)
- K130114PAINMASTER MCT PATCH2Cleared 510(K)
- K122744PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER2Cleared 510(K)
- K121757HEALTHMATEFOREVER2Cleared 510(K)
- K121353MINI PATCH2Cleared 510(K)
- K113321TENS BACK PAIN RELIEF SYSTEM2Cleared 510(K)
- K120500THE PAIN PILOT (A.K.A PAIN PILOT)2Cleared 510(K)
- K112392HIVOX BIOTEK INC.2Cleared 510(K)
- K113037PAIN-AID2Cleared 510(K)
- K110068MODEL PM30302Cleared 510(K)
- K112415LIFECARE ARM & LEG PAIN RELIEF SYSTEM2Cleared 510(K)
- K110716EVERYWAY LOW BACK PAIN RELIEF SYSTEM2Cleared 510(K)
- K110707CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR2Cleared 510(K)
- K102051PAIN BUDDY2Cleared 510(K)
- K102598HI-DOW-XP2Cleared 510(K)
- K100441XINIWAVE, MODEL XW-182Cleared 510(K)
- K100116LASERTOUCHONE (OTC)2Cleared 510(K)
- K091757OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-24072Cleared 510(K)
- K090042PAINMASTER MCT PATCH2Cleared 510(K)
- K060846THERAPEUTIC MASSAGE COMPANION2Cleared 510(K)
- K063743RHYTHM TOUCH Q 2-WAY2Cleared 510(K)
- K062532ELECTROPULSE - LOW BACK PAIN2Cleared 510(K)
- K063660OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-24072Cleared 510(K)
- K060222LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP2Cleared 510(K)
- K052785OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-24062Cleared 510(K)
- K0331225000Z SYSTEM (OTC)2Cleared 510(K)
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K221384
- 510(k) Type
- Special
- Applicant
- Hivox Biotek Inc.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/11/2022
- Days to Decision
- 29 days
- Submission Type
- Summary