Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 24
- Latest Decision
- 2003-09-04
Clearances · page 20 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K031315 | TMC ELECTRICAL SCOOTER, EASY 321 | Tmc Technology Corp. | INI | Class II | 2003-09-04 |
| K031313 | TMC ELECTRICAL SCOOTER, EASY 405 | Tmc Technology Corp. | INI | Class II | 2003-09-04 |
| K031314 | TMC ELECTRICAL SCOOTER, EASY 411 | Tmc Technology Corp. | INI | Class II | 2003-09-04 |
| K031551 | NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) | Vyteris, Inc. | KTB | Class II | 2003-08-20 |
| K031427 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 | Biomedical Life Systems, Inc. | IPF | Class II | 2003-08-19 |
| K031576 | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 | Surgitech, Inc. | IQI | Class I | 2003-07-31 |
| K030758 | COACH 888 | Wheelchair & Scooter Express | INI | Class II | 2003-07-31 |
| K032123 | SHOCKWAVE SUSPENSION WHEELCHAIR | Per4max Medical, LLC | IOR | Class I | 2003-07-31 |
| K031309 | KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320 | Kuann Dah Industry Co., Ltd. | INI | Class II | 2003-07-31 |
| K031910 | STAINLESS STEEL AQUATIC WHEELCHAIR | Db Perks & Associates , Ltd. | IOR | Class I | 2003-07-25 |
| K031998 | MODEL J-5 MVO-MONITOR | Myotronics-Noromed, Inc. | NUW | Class II | 2003-07-24 |
| K032133 | BRODA MODEL 587 MANUAL WHEELCHAIR | Broda Ent., Inc. | IOR | Class I | 2003-07-21 |
| K030403 | CEFAR REHAB 2 AND REHAB 2 PRO | Cefar Medical AB | IPF | Class II | 2003-07-17 |
| K020478 | ELECTROMEDICARIN 900 | Electromedicarin, S.A. | IPF | Class II | 2003-07-17 |
| K030692 | POWER LASER 90 | Andi Electromedical Aps | NHN | Class II | 2003-07-17 |
| K031227 | LORDEX POWER TRACTION EQUIPMENT | Ever Prosperous Instrument, Inc. | ITH | Class II | 2003-07-17 |
| K031045 | AEROLET TOILET LIFT, MODEL AER-01 | Economic Holland B.V. | INO | Class II | 2003-07-10 |
| K030760 | COACH 888W | Wheelchair & Scooter Express | ITI | Class II | 2003-07-10 |
| K031115 | RH-900 | Iomed, Inc. | KTB | Class II | 2003-07-10 |
| K031342 | JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II | Jason Marine Enterprises, Inc. | ITI | Class II | 2003-07-10 |
| K024307 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM | Sybaritic, Inc. | IMI | Class II | 2003-07-02 |
| K031884 | INTERFERENTIAL STIMULATOR, MODEL NETWAVE | Ryan Telemedicine | IPF | Class II | 2003-06-30 |
| K024181 | PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM | Prizm Medical, Inc. | IPF | Class II | 2003-06-26 |
| K030708 | SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 | Bio-Medical Research, Ltd. | NGX | Class II | 2003-06-25 |
| K023036 | CARE ETS | Care Rehab and Orthopaedic | IPF | Class II | 2003-06-19 |
| K024179 | PALOMAR LIGHTCUBE | Palomar Medical Products, Inc. | ILY | Class II | 2003-06-04 |
| K031017 | SYS*STIM 208 AND 208A | Mettler Electronics Corp. | IPF | Class II | 2003-05-30 |
| K030356 | COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 | Comfort Orthopedic Co., Ltd. | ITI | Class II | 2003-05-20 |
| K022998 | HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312 | Home Care Technology Co., Ltd. | IPF | Class II | 2003-05-20 |
| K030355 | COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 | Comfort Orthopedic Co., Ltd. | ITI | Class II | 2003-05-20 |
| K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 | Selectivemed Components, Inc. | EGJ | Class II | 2003-05-20 |
| K030507 | T.E.A.R. TECH3 MODEL #44TT03 | Vision Quest Industries, Inc. | IPF | Class II | 2003-05-20 |
| K031272 | C.T.M. MOBILITY SCOOTER, MODEL HS-120 | C.T.M. Homecare Product, Inc. | INI | Class II | 2003-05-20 |
| K030714 | PEAK MOTUS | Peak Performance Technologies, Inc. | LXJ | Class II | 2003-05-16 |
| K031289 | QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 | Sunrise Medical, Inc. | ITI | Class II | 2003-05-09 |
| K023230 | ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 | Western Clinical Technology Systems, Inc. | IPF | Class II | 2003-05-05 |
| K030017 | CHUMP | Colours 'N Motion | IOR | Class I | 2003-05-01 |
| K024175 | SUNPEX TECHNOLOGIES MODEL PW | Sunpex Technology Co., Ltd. | ITI | Class II | 2003-05-01 |
| K030759 | LITTLE COACH | Wheelchair & Scooter Express | INI | Class II | 2003-05-01 |
| K030432 | IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR | Imc-Heart Way LLC | ITI | Class II | 2003-05-01 |
| K022950 | MINIPHYSIONIZER 2.0 AND ELECTRODES | Physion, Inc. | EGJ | Class II | 2003-04-18 |
| K030427 | HP-3 HD ELECTRIC WHEELCHAIR | Imc-Heart Way LLC | ITI | Class II | 2003-04-18 |
| K030880 | VECTORSONIC, MODEL VU-270 | Metron Medical Australia, Pty, Ltd. | IMG | Class II | 2003-04-18 |
| K023621 | BIOFLEX PROFESSIONAL THERAPY SYSTEM | Meditech International, Inc. | ILY | Class II | 2003-04-10 |
| K030437 | RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM | Salton, Inc. | IRP | Class II | 2003-04-10 |
| K030395 | EMPI ACTION PATCH IONTOPHORESIS SYSTEM | Empi | EGJ | Class II | 2003-04-08 |
| K023001 | HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-326L | Home Care Technology Co., Ltd. | IPF | Class II | 2003-04-08 |
| K030707 | WU'S POWERED WHEELCHAIR, MAMBO 3 | Wu'S Tech Co., Ltd. | ITI | Class II | 2003-04-04 |
| K030882 | RABBIT MOBILE STANDING FRAME | R82 A/S | IPL | Class II | 2003-04-04 |
| K030709 | WU'S POWERED WHEELCHAIR, MAMBO 5 | Wu'S Tech Co., Ltd. | ITI | Class II | 2003-04-04 |
| K024325 | JI-EE ELECTRIC SCOOTER, ESTHETE ES 1 | Ji-Ee Industry Co., Ltd. | INI | Class II | 2003-04-04 |
| K030783 | FRONTIER MODEL X5 | Vestil Manufacturing Corp. | ITI | Class II | 2003-04-04 |
| K030893 | LEVO COMBI | Levo AG | IPL | Class II | 2003-04-02 |
| K030382 | SELITHERM, MODEL C100 | Selicor, Inc. | IMJ | Class II | 2003-04-01 |
| K030648 | VECTORSURGE 5 MODEL 470 | Metron Medical Australia, Pty, Ltd. | IPF | Class II | 2003-03-28 |
| K030878 | ACCOUSONIC, MODEL AS-270 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | 2003-03-28 |
| K024310 | NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY | Medx Electronics, Inc. | NHN | Class II | 2003-03-24 |
| K024329 | JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3 | Ji-Ee Industry Co., Ltd. | INI | Class II | 2003-03-21 |
| K030814 | INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 | Invacare Corp. | INI | Class II | 2003-03-20 |
| K030387 | C.T.M. MOBILITY SCOOTER, MODEL HS-890 | C.T.M. Homecare Product, Inc. | INI | Class II | 2003-03-11 |
| K022609 | SURGICAL PATIENT WARMER, MODEL PW820 JHU | Fisher & Paykel Healthcare, Ltd. | ILY | Class II | 2003-03-06 |
| K022855 | SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 | Bio-Medical Research, Ltd. | NGX | Class II | 2003-03-06 |
| K024346 | THE MULTILIFT | Services Industriels Savaria, Inc. | ING | Class II | 2003-03-04 |
| K023852 | STAIRFRIEND CURVED STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | ILK | Class II | 2003-03-04 |
| K030250 | IGLIDE MANUAL ASSIST WHEELCHAIR | Independence Technology, LLC | ITI | Class II | 2003-03-04 |
| K023997 | TENSCARE ULTIMA NMS/EMS | Tenscare, Ltd. | IPF | Class II | 2003-03-03 |
| K030254 | INTERFERENTIAL STIMULATOR, MODEL RTM1000 | Ryan Telemedicine | IPF | Class II | 2003-02-26 |
| K024345 | B.07 STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | ILK | Class II | 2003-02-26 |
| K030410 | ACCOUSONIC PLUS, MODEL AP-170 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | 2003-02-20 |
| K023050 | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI | Reliant Technologies, Inc. | IMG | Class II | 2003-02-14 |
| K021588 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5 | Biomedical Life Systems, Inc. | IPF | Class II | 2003-02-13 |
| K030226 | THOR DDII 830CL3 LASER SYSTEM | Thor Intl. | NHN | Class II | 2003-02-10 |
| K022696 | TEH LIN POWERED WHEELCHAIR, MODEL MDG-201 | Teh Lin Prosthetic & Orthopaedic, Inc. | ITI | Class II | 2003-02-07 |
| K024167 | STEP-SAVER STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | ILK | Class II | 2003-02-06 |
| K030060 | SPINEMED | Cert Health Sciences, LLC | ITH | Class II | 2003-02-05 |
| K024279 | NESS CHILDREN SYSTEM | Ness-Neuromuscular Electrical Stimulation Systems | IPG | Class I | 2003-02-05 |
| K022846 | SW-180 SHORTWAVE THERAPY UNIT | Ito Co., Ltd. | IMJ | Class II | 2003-01-28 |
| K023935 | TRILUMINA THERAPEUTIC LASER SYSTEM | Texas Applied Biomedical Services | NHN | Class II | 2003-01-28 |
| K023040 | WU'S 3-WHEELED NEO SCOOTER, WT-L3 | Wu'S Tech Co., Ltd. | INI | Class II | 2003-01-24 |
| K023168 | WU'S 3-WHEELED NEO SCOOTER, WT-T3B | Wu'S Tech Co., Ltd. | INI | Class II | 2003-01-24 |
| K023166 | WU'S 3-WHEELED NEO SCOOTER, WT-M4 | Wu'S Tech Co., Ltd. | INI | Class II | 2003-01-24 |
| K023148 | EPW POWERED WHEELCHAIR, GP-201 | Emg Technology Co., Ltd. | ITI | Class II | 2003-01-24 |
| K022697 | TEH LIN JUPITER POWER CHAIR, MODEL TL-320 | Teh Lin Prosthetic & Orthopaedic, Inc. | ITI | Class II | 2003-01-24 |
| K022602 | DRX3000 | Axiom Usa., Inc. | ITH | Class II | 2003-01-23 |
| K023446 | MEDS-3 NEUROMUSCULAR STIMULATOR | Medical Equipment Device Specialists | IPF | Class II | 2003-01-13 |
| K023439 | MEDS-4 NEUROMUSCULAR STIMULATOR | Medical Equipment Device Specialists | IPF | Class II | 2003-01-13 |
| K024316 | NIM-PRS | Medtronic Xomed, Inc. | IKN | Class II | 2003-01-06 |
| K023993 | GALAXY SERIES WHEELCHAIR | Evermed Corp. | IOR | Class I | 2002-12-27 |
| K023961 | SCOUT BOSS | Burke, Inc. | ITI | Class II | 2002-12-24 |
| K024055 | TILITE EVO | Tisport, LLC | IOR | Class I | 2002-12-20 |
| K024036 | PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 | Johari Digital Healthcare , Ltd. | IPF | Class II | 2002-12-20 |
| K023160 | DRX5000 | Axiom Usa., Inc. | ITH | Class II | 2002-12-20 |
| K024030 | MILLENNIUM SERIES MANUAL WHEELCHAIRS | Evermed Corp. | IOR | Class I | 2002-12-12 |
| K023147 | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 | Bortec Biomedical, Ltd. | IKN | Class II | 2002-12-12 |
| K022888 | ACUBEAM, SUPER NOVA, DIO | Light Force Therapy, Inc. | ILY | Class II | 2002-12-11 |
| K023161 | SMARTSTEP SYSTEM | Andante Medical Device, Ltd. | IRN | Class II | 2002-12-10 |
| K023347 | VITAL STIM | Chattanooga Group | IPF | Class II | 2002-12-06 |
| K023574 | GIZMO | Freedom Designs, Inc. | IOR | Class I | 2002-12-04 |
| K023485 | EXPLORER POWERED WHEELCHAIR | Evermed Corp. | ITI | Class II | 2002-12-02 |
| K022698 | SCOOTER MARS SERIES, MODEL TL-588 | Teh Lin Prosthetic & Orthopaedic, Inc. | INI | Class II | 2002-12-02 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.