Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 21
- Latest Decision
- 2004-03-31
Clearances · page 19 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K040561 | MANUAL WHEELCHAIR SERIES | Shanghai Wheelchair Factory | IOR | Class I | 2004-03-31 |
| K033986 | MLT-1000 IR LASER SYSTEM | Medical Laser Therapeutics LP | ILY | Class II | 2004-03-29 |
| K032816 | QUANTUM LIGHT THERAPY SYSTEM | Stargate International, Inc. | NHN | Class II | 2004-03-26 |
| K033460 | CHEETAH WHEELCHAIR | R82 A/S | IOR | Class I | 2004-03-26 |
| K040306 | HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7 | Biomedical Life Systems, Inc. | IPF | Class II | 2004-03-23 |
| K023060 | ACCULASER PRO4 | Acculaser, Inc. | NHN | Class II | 2004-03-19 |
| K033923 | TH0R DDII IR LAMP SYSTEM | Thor Intl. | ILY | Class II | 2004-03-17 |
| K040121 | DERMAWAVE 5000 COMBI MAX SYSTEM | Dermawave, LLC | IMG | Class II | 2004-03-17 |
| K040320 | SINON POWER WHEELCHAIR, SN-P401 | Sinon Corporation | ITI | Class II | 2004-03-12 |
| K033555 | KENKOWAVE INFRARED PAIN TREATMENT SYSTEM | Kaylight Corporation | ILY | Class II | 2004-03-02 |
| K040319 | SINON POWER WHEELCHAIR, SN-W401 | Sinon Corporation | ITI | Class II | 2004-02-20 |
| K040020 | C.T.M. POWER CHAIR, MODEL HS-1000 | C.T.M. Homecare Product, Inc. | ITI | Class II | 2004-02-18 |
| K033768 | ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE | Altus Medical, Inc. | ILY | Class II | 2004-02-17 |
| K040097 | MEDLINE STRIDER MIDI 3 | Medline Industries, Inc. | INI | Class II | 2004-02-13 |
| K032446 | MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4 | Medline Industries, Inc. | INI | Class II | 2004-02-12 |
| K032216 | BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM | Bioptron AG | NHN | Class II | 2004-02-04 |
| K032765 | STREET | Permobil AB | ITI | Class II | 2004-01-30 |
| K040044 | HEEL SNUGGLER, MODEL 99047 | Respironics, Inc. | MPO | Class I | 2004-01-27 |
| K031621 | HERO 1, MODEL LY-ESB220 | Comfort Orthopedic Co., Ltd. | IPL | Class II | 2004-01-22 |
| K033019 | SUNPEX TECHNOLOGIES MODEL SE03 | Sunpex Technology Co., Ltd. | INI | Class II | 2004-01-22 |
| K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | Cynosure, Inc. | ISA | Class I | 2004-01-22 |
| K032101 | POWERSTAND STAND-UP WHEELCHAIR | The Standing Co., Inc. | IPL | Class II | 2004-01-22 |
| K031995 | COMPREHENSIVE NEUROMUSCULAR PROFILER | Medical Technologies Unlimited, Inc. | IKN | Class II | 2004-01-07 |
| K033469 | GENESIS VERTICAL PLATFORM LIFT | Garaventa Accessibility | ING | Class II | 2004-01-07 |
| K033514 | CODA CX1 MOTION ANALYSIS SYSTEM | Charnwood Dynamics , Ltd. | LXJ | Class II | 2004-01-06 |
| K033829 | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 | Bruno Independent Living Aids, Inc. | ILK | Class II | 2003-12-29 |
| K033192 | RH-950 | Iomed, Inc. | KTB | Class II | 2003-12-22 |
| K033206 | EPW FOLDABLE POWER WHEELCHAIR, EPW-03 | Emg Technology Co., Ltd. | ITI | Class II | 2003-12-18 |
| K031618 | COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 | Comfort Orthopedic Co., Ltd. | IPL | Class II | 2003-12-18 |
| K033220 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 | Tung Keng Enterprise Co., Ltd. | INI | Class II | 2003-12-18 |
| K033240 | BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 | Tung Keng Enterprise Co., Ltd. | INI | Class II | 2003-12-18 |
| K031711 | TANGO, MODELS, BP1 | American Bantex Corp. | ITI | Class II | 2003-12-18 |
| K033827 | UB 140 | Rivertrail Mobility | ITI | Class II | 2003-12-18 |
| K032955 | AUTOMOVE, MODEL AM800 | Danmeter A/S | IPF | Class II | 2003-12-15 |
| K033752 | BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 | Bruno Independent Living Aids, Inc. | ILK | Class II | 2003-12-12 |
| K031612 | ALT LASER, MODEL VTR 75 | Avicenna Laser Technology, Inc. | ILY | Class II | 2003-12-11 |
| K031077 | VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM | Chattanooga Group | IMG | Class II | 2003-12-11 |
| K033544 | ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 | Everyway Medical Instruments Co.,Ltd | IPF | Class II | 2003-12-10 |
| K024027 | LIGHTWAVE INFRARED LAMPS LW10D AND LW30D | Skytech Enterprises, Inc. | ILY | Class II | 2003-12-03 |
| K031116 | VECTRA (INTELECT) EPR ULTRASOUND | Chattanooga Group | IMI | Class II | 2003-12-03 |
| K032968 | TRSANSDERM IONTO SYSTEM | Mattioli Engineering Corp. | EGJ | Class II | 2003-12-02 |
| K033031 | TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR | Taiwan King Strong Co., Ltd. | IOR | Class I | 2003-12-02 |
| K033100 | TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01 | Taiwan King Strong Co., Ltd. | ITI | Class II | 2003-12-02 |
| K032488 | WU'S 3-WHEELED NEO SCOOTER, WT-T3D | Wu'S Tech Co., Ltd. | INI | Class II | 2003-12-02 |
| K032643 | JUSTWIN SCOOTER, JS-3013 | Joy Ride Tech Co., Ltd. | INI | Class II | 2003-12-02 |
| K032645 | JUSTWIN SCOOTER, JS-3014 | Joy Ride Tech Co., Ltd. | INI | Class II | 2003-12-02 |
| K033452 | CWAS 1000 | Fasstech | IKN | Class II | 2003-11-28 |
| K033370 | POWERED WHEELCHAIR, MODEL FR168W | Freerider Corp | ITI | Class II | 2003-11-28 |
| K033015 | AXIOM BIOLASER LLLT SERIES-3 | Axiom Usa., Inc. | NHN | Class II | 2003-11-25 |
| K033438 | BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 | Bruno Independent Living Aids, Inc. | ILK | Class II | 2003-11-20 |
| K032379 | QUASAR, MODEL MD21 | Quantum Skincare, Inc. | ILY | Class II | 2003-11-20 |
| K031375 | BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 | Besmed Health Business Corp | IPF | Class II | 2003-11-20 |
| K033035 | TLC MODELS ULK-H AND ULT-H INFRARED LAMPS | Tlc Marketing, Inc. | ILY | Class II | 2003-11-20 |
| K032787 | NEUROLASE, MODELS 150V, 150C, 1064 | Spectrum Laser & Technologies | ILY | Class II | 2003-11-20 |
| K032879 | NAVIGATOR I | Adaptive Healthcare Technologies, Inc. | INI | Class II | 2003-11-13 |
| K033204 | ESG 4-WHEEL SCOOTER, ESG-03 | Emg Technology Co., Ltd. | INI | Class II | 2003-11-12 |
| K032669 | Y.E.S. POWERED WHEELCHAIR, MODEL T200 | Yeou Eir Shuen Machinery Co., Ltd. | ITN | Class I | 2003-11-12 |
| K033097 | TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02 | Taiwan King Strong Co., Ltd. | ITI | Class II | 2003-11-12 |
| K031820 | ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660 | Multinational | IPF | Class II | 2003-11-12 |
| K032617 | WU'S 4-WHEELED SCOOTER, WT-L4JR | Wu'S Tech Co., Ltd. | INI | Class II | 2003-11-12 |
| K032512 | Y.E.S POWERED WHEELCHAIR. T180 | Yeou Eir Shuen Machinery Co., Ltd. | ITI | Class II | 2003-11-12 |
| K033219 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 | Tung Keng Enterprise Co., Ltd. | INI | Class II | 2003-11-12 |
| K033239 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 | Tung Keng Enterprise Co., Ltd. | INI | Class II | 2003-11-12 |
| K033032 | WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR | Wu'S Tech Co., Ltd. | INI | Class II | 2003-11-10 |
| K032880 | SUMMIT STAIRWAY LIFT | Summit Lifts, Inc. | ILK | Class II | 2003-11-10 |
| K033241 | BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 | Tung Keng Enterprise Co., Ltd. | INI | Class II | 2003-11-10 |
| K031862 | SPINERX-LDM | Spinerx Technology | ITH | Class II | 2003-10-31 |
| K033263 | K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT | Track Corporation | ITI | Class II | 2003-10-31 |
| K024013 | SUN-RAIN ULTRASONIC THERAPY, SU-100 | Sun-Rain System Corp. | IMI | Class II | 2003-10-31 |
| K033125 | HANDIVIPP | Handinor USA, Inc. | IOR | Class I | 2003-10-30 |
| K032731 | MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS | Turbo Wheelchair Co., Inc. | IOR | Class I | 2003-10-30 |
| K033141 | MECHANICAL WHEEHCHAIR | Pacific Medical Suppliers, Inc. | IOR | Class I | 2003-10-30 |
| K023000 | HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES | Home Care Technology Co., Ltd. | IPF | Class II | 2003-10-29 |
| K033140 | NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P | Everyway Medical Instruments Co.,Ltd | IPF | Class II | 2003-10-29 |
| K032941 | AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Rich-Mar Corp. | IPF | Class II | 2003-10-22 |
| K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) | Dynatronics Corp. | IMI | Class II | 2003-10-22 |
| K032449 | THERMASSAGE ENERGY PRODUCT, MODEL HY5000 | Migun Medical Instrument Co. , Ltd. | JFB | Class II | 2003-10-22 |
| K032989 | MEDI-HEAT INFANT HEEL WARMER | Mediheat, Inc. | MPO | Class I | 2003-10-22 |
| K032919 | C.T.M. MOBILITY SCOOTER, MODEL HS-250 | C.T.M. Homecare Product, Inc. | INI | Class II | 2003-10-15 |
| K032178 | RHYTHM TOUCH Q 2-WAY | Shockim Enterprises, Ltd. | IPF | Class II | 2003-10-15 |
| K031769 | E-STRIP | Eemso, Inc. | EGJ | Class II | 2003-10-14 |
| K023209 | INSIGHT MILLENNIUM III | Fasstech | IKN | Class II | 2003-10-10 |
| K030998 | MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 | Healthonics, Inc. | IPF | Class II | 2003-10-10 |
| K032793 | US-100 PORTABLE ULTRASOUND THERAPY UNIT | Ito Co., Ltd. | IMI | Class II | 2003-10-09 |
| K024361 | EM PROBE, EM PAD | Em Probe, Inc. | ILY | Class II | 2003-10-09 |
| K032918 | C.T.M. MOBILITY SCOOTER, MODEL HS-235 | C.T.M. Homecare Product, Inc. | INI | Class II | 2003-10-06 |
| K030757 | COACH 777-4 | Wheelchair & Scooter Express | INI | Class II | 2003-10-06 |
| K032441 | F-10 FOLDING POWER CHAIR | Wheelchair & Scooter Express | ITI | Class II | 2003-10-06 |
| K030756 | COACH 777-3 | Wheelchair & Scooter Express | INI | Class II | 2003-10-06 |
| K032231 | MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER | Medx Electronics, Inc. | ILY | Class II | 2003-10-03 |
| K032277 | JUSTWIN SCOOTER, MODEL JS-401 | Joy Ride Tech Co., Ltd. | INI | Class II | 2003-09-24 |
| K032402 | RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T, | Convaid Products, Inc. | IOR | Class I | 2003-09-24 |
| K032505 | AIR PRESS MASSAGER | Telebrands Corp | IRP | Class II | 2003-09-24 |
| K032489 | WU'S 4-WHEELED NEO SCOOTER, WT-M4JR | Wu'S Tech Co., Ltd. | INI | Class II | 2003-09-24 |
| K031897 | PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER | Imc-Heart Way LLC | INI | Class II | 2003-09-23 |
| K032440 | F-11 FOLDING POWER CHAIR | Wheelchair & Scooter Express | ITI | Class II | 2003-09-23 |
| K031499 | DIOBEAM 830 | Soft-Core Texas, Inc. | NHN | Class II | 2003-09-16 |
| K032229 | QUANTUM WARP 10 LIGHT DELIVERY SYSTEM | Quantum Devices, Inc. | ILY | Class II | 2003-09-12 |
| K032652 | RS-4I MUSCLE STIMULATOR FAMILY | Rs Medical | IPF | Class II | 2003-09-12 |
| K030622 | AXIOM BIOLASER LLLT SERIES-1 | Axiom Usa., Inc. | NHN | Class II | 2003-09-09 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.