Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 22
- Latest Decision
- 2005-12-29
Clearances · page 17 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K053266 | MYOTRAC INFINITI | Thought Technology , Ltd. | IPF | Class II | 2005-12-29 |
| K053503 | VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) | Vax-D Medical Technologies USA, L.C. | ITH | Class II | 2005-12-28 |
| K052706 | A-200 POWERED WHEELCHAIR | Otto Bock Healthcare LP | ITI | Class II | 2005-12-27 |
| K052307 | BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM | Beamline Corporation | ILY | Class II | 2005-12-16 |
| K050921 | EASYSTIM NMS-28 | Easy Med Instrument Co., Ltd. | IPF | Class II | 2005-12-12 |
| K052340 | DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM | Alfa Tech Medical Systems, Ltd. | IMG | Class II | 2005-12-09 |
| K053201 | CURAE'LASE CL1000 IR LASER SYSTEM | Curae'Lase, Inc. | ILY | Class II | 2005-12-09 |
| K052586 | A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P | Taiwan an I Co., Ltd. | IOR | Class I | 2005-12-09 |
| K053192 | MODEL 418 SERIES WALKERS | Mjm International Corporation | NXE | Class I | 2005-12-05 |
| K052814 | LUMINA 1600, 3300 AND 6600 SYSTEMS | Usa Laser Biotech, Inc. | ILY | Class II | 2005-11-30 |
| K052969 | SLENDERTONE GYMBODY, MODEL 512-01 | Bio-Medical Research, Ltd. | NGX | Class II | 2005-11-16 |
| K052647 | CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55. | American Spine Center, Ltd. | ILY | Class II | 2005-11-09 |
| K052019 | NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE | North Coast Medical, Inc. | EGJ | Class II | 2005-11-04 |
| K052496 | PRIMECHAIR | Dalton Medical Corp. | ITI | Class II | 2005-11-04 |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Excel Tech. , Ltd. | IKN | Class II | 2005-10-28 |
| K052558 | VCS, MODEL S4T | Cycling and Health Tech. Industry R&D Center/Chc | INI | Class II | 2005-10-27 |
| K051548 | IRRADIA MID - LASER (S3) | Irradia AB | ILY | Class II | 2005-10-24 |
| K052673 | KING I POWERED SCOOTER, MODEL CTL-11 | King I Tech Corporation | INI | Class II | 2005-10-17 |
| K051680 | DYNATRON DX2 TRACTION UNIT | Dynatronics Corp. | ILY | Class II | 2005-10-11 |
| K052378 | PROASIA, MODEL L3402 | Proasia Limited | INI | Class II | 2005-10-07 |
| K052486 | PROASIA, MODEL L4501 | Proasia Limited | INI | Class II | 2005-10-07 |
| K052681 | START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI) | Otto Bock Healthcare LP | IOR | Class I | 2005-10-06 |
| K052468 | YK9000 SERIES MANUAL WHEELCHAIR | Intco Metal Products (Zhenjiang) Co., Ltd. | IOR | Class I | 2005-10-05 |
| K052063 | HUANQIU HEATING LAMP | A & A Medical Supplies, Inc. | ILY | Class II | 2005-09-30 |
| K051861 | THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 | Savion Industries, Ltd. | INK | Class II | 2005-09-28 |
| K051369 | SYRYKER SORANO WHEELCHAIR | Stryker Canada | IOR | Class I | 2005-09-26 |
| K051537 | HILT FAMILY LASER: HILT I, HILT II, HILT III | Cynosure, Inc. | ILY | Class II | 2005-09-26 |
| K052521 | NISSIN SERIES MECHANICAL WHEELCHAIR | Nissin Medical Industries Co., Ltd. | IOR | Class I | 2005-09-26 |
| K052559 | WU'S POWERED WHEELCHAIR, MAMBO 2 | Wu'S Tech Co., Ltd. | ITI | Class II | 2005-09-26 |
| K051938 | TRITON/TRU-TRAC/TX TRACTION DEVICES | Chattanooga Group | ITH | Class II | 2005-09-21 |
| K052008 | IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 | Imc-Heart Way LLC | ITI | Class II | 2005-09-16 |
| K050524 | EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 | Marda Medical, Inc. | IRQ | Class I | 2005-09-14 |
| K051922 | ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 | Cynosure, Inc. | ILY | Class II | 2005-09-14 |
| K052353 | Z-CHAIR | Pride Mobility Products Corp. | ITI | Class II | 2005-09-09 |
| K051130 | VCS S3Y | Cycling and Health Tech. Industry R&D Center/Chc | INI | Class II | 2005-09-09 |
| K052375 | ALILIFE STAND UP POWERED WHEELCHAIR, HC-300 | Alilife Technological Co., Ltd. | IPL | Class II | 2005-09-09 |
| K033231 | SPINA SYSTEM | North American Medical Corp (Nam) | ITH | Class II | 2005-09-09 |
| K043373 | DOLOTENS DENTAL TM 1 | Neuromuscular Technologies, Inc. | KZM | Class II | 2005-09-02 |
| K051473 | LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 | Lerado China Limited | INI | Class II | 2005-08-31 |
| K051816 | LUMIWAVE 1X4 INFRARED THERAPY DEVICE | Biocare Systems, Inc. | ILY | Class II | 2005-08-26 |
| K051709 | HIPPOCAMPE WHEELCHAIR | Vipamat Technologie | IQC | Class II | 2005-08-15 |
| K051131 | VCS S3T | Cycling and Health Tech. Industry R&D Center/Chc | INI | Class II | 2005-08-15 |
| K051302 | EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR | Medline Industries, Inc. | IOR | Class I | 2005-08-15 |
| K051819 | C CHANGE SOLUTION WARMER | C Change Surgical, LLC | LHC | Class I | 2005-08-15 |
| K051135 | AXIOM NVP8500 | Axiom Worldwide, Inc. | IPF | Class II | 2005-08-11 |
| K050687 | AXIOM EPS8000 | Axiom Worldwide, Inc. | IPF | Class II | 2005-07-28 |
| K051681 | DERMILLUME RED, MODEL HR1000 | Care Electronics, Inc. | ILY | Class II | 2005-07-27 |
| K051631 | EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 | Stargate International, Inc. | NHN | Class II | 2005-07-27 |
| K051261 | DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE | Dynatronics Corp. | ILY | Class II | 2005-07-25 |
| K043055 | TERRAQUANT MQ2000 LASER THERAPY DEVICE | Escada International, Inc. | ILY | Class II | 2005-07-25 |
| K051538 | AVANTICARE, MODEL SA4022 | Lerado China Limited | INI | Class II | 2005-07-21 |
| K051256 | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | Noble Fiber Technologies, Inc. | ISH | Class I | 2005-07-21 |
| K050410 | HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ) | Hwang Sun Enterprise Co., Ltd. | IMI | Class II | 2005-07-14 |
| K050342 | THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM | Theralase, Inc. | NHN | Class II | 2005-07-11 |
| K050507 | SMARTECH, MODEL HOLI I | Cycling and Health Tech. Industry R&D Center | INI | Class II | 2005-07-07 |
| K050793 | LANDLEX MODEL S400X | Cycling and Health Tech. Industry R&D Center | INI | Class II | 2005-07-07 |
| K043353 | OMEGA EXCEL/XP LASER SYSTEM | Advanced Medical Technologies, Inc. | NHN | Class II | 2005-07-01 |
| K051481 | JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP | Jan Mao Industries Co., Ltd. | IOR | Class I | 2005-06-29 |
| K051482 | JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP | Jan Mao Industries Co., Ltd. | IOR | Class I | 2005-06-29 |
| K050847 | IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A | Theratech, Inc. | IPF | Class II | 2005-06-17 |
| K042686 | ENERGEX | Energex Systems, Inc. | NHH | Class II | 2005-06-16 |
| K050370 | PALOMAR LUXIR HANDPIECE | Palomar Medical Technologies, Inc. | ILY | Class II | 2005-06-15 |
| K051387 | LEVO COMFORT II | Levo AG | IPL | Class II | 2005-06-10 |
| K043558 | XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A | Chongqing Xinfeng Medical Instruments Co., Ltd. | ILY | Class II | 2005-06-06 |
| K043306 | SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR | Skylark Device & Systems Co., Ltd. | ILY | Class II | 2005-06-06 |
| K051118 | MODEL TL-360 POWER SCOOTER | Teh Lin Prosthetic & Orthopaedic, Inc. | INI | Class II | 2005-05-31 |
| K051116 | MODEL TL-560 POWER SCOOTER | Teh Lin Prosthetic & Orthopaedic, Inc. | INI | Class II | 2005-05-31 |
| K050595 | FT2000 SEQUENCER FOR MUSCLE STIMULATOR | Midwest Development | IPF | Class II | 2005-05-23 |
| K051090 | X-CHANGE | Meyra | IOR | Class I | 2005-05-13 |
| K051046 | PAINACEA MODEL XR8 INFRARED HEAT LAMP | Atlantis Luminescent Products, LLC | ILY | Class II | 2005-05-10 |
| K043586 | LASER SYS*STIM 540, MODEL ME 540 | Mettler Electronics Corp. | ILY | Class II | 2005-05-06 |
| K050022 | MEDX HOME | Medx Electronics, Inc. | ILY | Class II | 2005-05-05 |
| K050941 | BRIX WHEELCHAIR | Meyra, Inc. | IOR | Class I | 2005-05-05 |
| K051013 | SPINEMED S200B/S200C | Cert Health Sciences, LLC | ITH | Class II | 2005-04-27 |
| K050708 | LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000 | Lerado Oversea Ltd. Twn Branch (Bvi) | IOR | Class I | 2005-04-26 |
| K050792 | LANDLEX, MODEL S300X | Cycling and Health Tech. Industry R&D Center | INI | Class II | 2005-04-21 |
| K050560 | EUROCHAIR | Meyra, Inc. | IOR | Class I | 2005-04-21 |
| K050691 | R. POON MEDICAL PRODUCTS WHEELCHAIRS | R. Poon Medical Products Co., Ltd. | IOR | Class I | 2005-04-21 |
| K050707 | LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000 | Lerado Oversea Ltd. Twn Branch (Bvi) | IOR | Class I | 2005-04-18 |
| K050046 | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S | Compex Technologies, Inc. | IPF | Class II | 2005-04-13 |
| K050280 | RUNABOUT WHEELCHAIR | Access Point Medical, LLC | IOR | Class I | 2005-04-11 |
| K050279 | AXS-1 LITE WHEELCHAIR | Access Point Medical, LLC | IOR | Class I | 2005-04-11 |
| K050281 | TRANSPORT SERIES TRANSPORT CHAIR | Access Point Medical, LLC | IOR | Class I | 2005-04-11 |
| K050345 | CIE FOLDAWAY WHEELCHAIR | Carlsbad International Export, Inc. | IOR | Class I | 2005-03-29 |
| K050070 | K-LASER, MODELS 3,4,4D,6D | Eltech S.R.L | ILY | Class II | 2005-03-25 |
| K042482 | BASS ANTALGIC-TRAK | Traction Masters, LLC | ITH | Class II | 2005-03-21 |
| K042699 | ABILITY POWER GURNEY | Gator Custom Mobility, Inc. | ITI | Class II | 2005-03-16 |
| K043317 | OMNILUX PLUS | Photo Therapeutics Limited | ILY | Class II | 2005-03-15 |
| K043511 | SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 | Soleus Champ International Co., Ltd. | ITI | Class II | 2005-03-14 |
| K050042 | WU'S 4-WHEELED NEO SCOOTER, WT-XL4 | Wu'S Tech Co., Ltd. | INI | Class II | 2005-03-14 |
| K024258 | NEUROTECH KNEEHAB | Bio-Medical Research, Ltd. | IPF | Class II | 2005-03-04 |
| K041565 | LAZRPULSR 4X | Led Healing Light, LLC | NHN | Class II | 2005-03-03 |
| K042813 | BIOBEAM NARROW BAND LIGHT THERAPY DEVICES | Life Without Pain, LLC | ILY | Class II | 2005-02-25 |
| K041885 | BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS | Meditech International, Inc. | ILY | Class II | 2005-02-24 |
| K040905 | WELLNESS/JOLIVETE | Tohkai Precision Ind. , Ltd. | IRP | Class II | 2005-02-23 |
| K050290 | LERADO, COSCO | Lerado Oversea Ltd. Twn Branch (Bvi) | IOR | Class I | 2005-02-18 |
| K043435 | QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR | Sunrise Medical | ITI | Class II | 2005-02-11 |
| K050264 | STEALTH PRODUCTS SEATING SYSTEM | Stealth Products | ITI | Class II | 2005-02-11 |
| K050011 | WU'S POWERED WHEELCHAIR, MAMBO F 120 | Wu'S Tech Co., Ltd. | ITI | Class II | 2005-02-11 |
| K050010 | WU'S POWERED WHEELCHAIR, MAMBO 36X | Wu'S Tech Co., Ltd. | ITI | Class II | 2005-02-11 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.