Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 20
- Latest Decision
- 2001-02-15
Clearances · page 23 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K010094 | A & I WHEELCHAIRS | Taiwan an I Co., Ltd. | IOR | Class I | 2001-02-15 |
| K010075 | TEKNIQUE | Hoveround Corp. | ITI | Class II | 2001-02-14 |
| K010102 | SONIC MODEL SO-300 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | 2001-02-09 |
| K003862 | MADA WHEELCHAIRS | Mada Medical Products, Inc. | IOR | Class I | 2001-01-12 |
| K010011 | TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM | Accelerated Rehab Designs, Inc. | ITI | Class II | 2001-01-12 |
| K003783 | MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER | Medical Depot, Inc. | IOR | Class I | 2001-01-12 |
| K003176 | BIOEMG II AND BIOJVA | Bio-Research Associates, Inc. | KZM | Class II | 2001-01-04 |
| K003815 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER | Merits Health Products., Inc. | INI | Class II | 2000-12-27 |
| K993406 | TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 | Permobil AB | ITI | Class II | 2000-12-18 |
| K003048 | ALL TERRAIN WHEELCHAIR (ATW) | Roll-Ability (Pty) , Ltd. | IOR | Class I | 2000-12-15 |
| K001491 | QUICKIE 2 POWER ASSIST WHEELCHAIR | Sunrise Medical, Inc. | ITI | Class II | 2000-12-15 |
| K002616 | ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS | Electric Mobility, LLC | INI | Class II | 2000-12-11 |
| K991613 | SW ULTRASOUND, MODELS 331, 311, 333 | Starbene | IMI | Class II | 2000-12-08 |
| K002859 | SSW-STERILE SOLUTION WARMER | Kmi Kolster Methods, Inc. | LHC | Class I | 2000-11-16 |
| K003287 | MODEL K7 EVALUATION DEVICE | Myotronics-Noromed, Inc. | KZM | Class II | 2000-11-06 |
| K002390 | QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H | Lsi Intl., Inc. | JFB | Class II | 2000-11-02 |
| K001179 | SUPER NOVA, ACUBEAM | Light Force Therapy, Inc. | ILY | Class II | 2000-10-27 |
| K000739 | EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR | Otto Bock Orthopedic Industry, Inc. | ITI | Class II | 2000-10-24 |
| K002943 | WHEELCHAIR, MECHANICAL SERIES MODEL 3100 | Mada Medical Products, Inc. | IOR | Class I | 2000-10-23 |
| K001522 | TRANSQ3 | Iomed, Inc. | KTB | Class II | 2000-10-18 |
| K002673 | EZ-COMFORT TRANSPORTER 2000 SERIES | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | IOR | Class I | 2000-10-11 |
| K002983 | C.T.M. POWER CHAIR, MODEL HS-5600 | Warepalmy Enterprise, LLC (Usa) | ITI | Class II | 2000-10-11 |
| K002876 | JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM | Suiter Medical LLC | IOR | Class I | 2000-10-11 |
| K001835 | IRV2000 INDIVIDUAL RECREATIONAL VEHICLE | Trac About, Inc. | INI | Class II | 2000-10-11 |
| K002669 | EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | IOR | Class I | 2000-10-11 |
| K002318 | UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES | United Chair Mfg., LLC | INO | Class II | 2000-10-11 |
| K002670 | EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | IOR | Class I | 2000-10-11 |
| K002671 | EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR | Jiangsu Intco Medical Equipment & Supply Co., Ltd. | IOR | Class I | 2000-10-11 |
| K002104 | COMBINED PHYSIOLOGICAL MONITORING SYSTEM | Maryrose Cusimano, Ph.D. & Scott Zeff | IKN | Class II | 2000-10-10 |
| K001056 | OLYMPIC WARM-UP | Olympic Medical Corp. | ILY | Class II | 2000-09-29 |
| K001970 | JET 1 POWERED WHEELCHAIR | Pride Mobility Products Corp. | ITI | Class II | 2000-09-26 |
| K001937 | MEDLINE ELECTRONIC POSITIONING CHAIR | Medline Industries, Inc. | INO | Class II | 2000-09-22 |
| K000678 | RAEBBITT/EVOLUTION POWERED WHEELCHAIR | Otto Bock Orthopedic Industry, Inc. | ITI | Class II | 2000-09-18 |
| K001869 | DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE | Medicotest A/S | IKT | Class II | 2000-09-18 |
| K001800 | ACCUWARM EMG HEAT LAMP | Rjl Associates, LLC | IKN | Class II | 2000-09-12 |
| K001712 | 3D ACTIVETRAC | The Saunders Group | ITH | Class II | 2000-08-31 |
| K002260 | SPINA SYSTEM | North American Medical Corporation (Nam) | ITH | Class II | 2000-08-25 |
| K000356 | C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580 | Warepalmy Enterprise, LLC (Usa) | INI | Class II | 2000-08-25 |
| K002157 | RANGER II M6, MODEL IN-888WNL | Invacare Corp. | ITI | Class II | 2000-08-25 |
| K002202 | KARMAN WHEELCHAIR | Karman Healthcare, Inc. | IOR | Class I | 2000-08-25 |
| K000354 | C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570 | Warepalmy Enterprise, LLC (Usa) | INI | Class II | 2000-08-25 |
| K001909 | PLAINSENSE WHEELCHAIR | Plainsense Wheelchairs, Inc. | IOR | Class I | 2000-08-25 |
| K002167 | KARMAN WHEELCHAIR | Karman Healthcare, Inc. | IOR | Class I | 2000-08-25 |
| K001923 | REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 | Gendron, Inc. | ITI | Class II | 2000-08-25 |
| K002317 | MODEL 9000 BARIATRIC WHEELCHAIR | Invacare Corp. | IOR | Class I | 2000-08-25 |
| K000808 | RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE | Rich-Mar Corp. | IPF | Class II | 2000-08-25 |
| K001562 | NEURO SCAN MEDICAL SYSTEMS A4000 | Neuro Scan Labs | IKN | Class II | 2000-08-16 |
| K000796 | MAGIC MOBILITY 4 X 4 WHEELCHAIR | Vestil Manufacturing Corp. | ITI | Class II | 2000-08-11 |
| K001860 | PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA | Homedics, Inc. | IMC | Class II | 2000-08-10 |
| K002205 | CARONY | Bruno Independent Living Aids, Inc. | IOR | Class I | 2000-08-10 |
| K002171 | INVACARE LIFT CHAIR | Invacare Corp. | INO | Class II | 2000-08-10 |
| K000114 | RS-4M+MUSCLE STIMULATOR | Rs Medical | IPF | Class II | 2000-08-10 |
| K000574 | IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) | Wr Medical Electronics Co. | EGJ | Class II | 2000-08-09 |
| K000084 | ENRAF-NONIUS SONOPULS 190 SYSTEM | Henley Healthcare, Inc. | IMI | Class II | 2000-08-04 |
| K000593 | SONIC, MODEL SO-100 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | 2000-08-04 |
| K002170 | MODEL 9000 PEDIATRIC WHEELCHAIR | Invacare Corp. | IOR | Class I | 2000-08-04 |
| K001410 | PHORESOR MODEL PM2000 | Iomed, Inc. | KTB | Class II | 2000-08-01 |
| K000204 | WIN-1 TANGO | Duracare Medical Equipment, L.C. | ITI | Class II | 2000-08-01 |
| K001777 | MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS | Invacare Corp. | ITI | Class II | 2000-07-24 |
| K001391 | BONUS MECHANICAL WHEELCHAIR | Bonus Ent. Corp. | IOR | Class I | 2000-07-24 |
| K001890 | SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR) | Otto Bock Orthopaedische Industrie, Kg. | IOR | Class I | 2000-07-24 |
| K001361 | JILCO TRACTION-FLEXION CHAIR | Jilco Enterprises | ITH | Class II | 2000-07-19 |
| K000869 | LA PERSONAL SCOOTER | Assembled Products Corp. | INI | Class II | 2000-07-19 |
| K993684 | SPINAL PAD | Bioscan, Inc. | ILY | Class II | 2000-07-19 |
| K993420 | CONTROL SOLUTIONS INC, MODEL CS3101 | Control Solutions, Inc. | IPF | Class II | 2000-07-19 |
| K993685 | BIOPACK | Bioscan, Inc. | ILY | Class II | 2000-07-18 |
| K993686 | LIGHT PATCH | Bioscan, Inc. | ILY | Class II | 2000-07-18 |
| K001298 | J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR | Roll-Ability (Pty) , Ltd. | IOR | Class I | 2000-07-18 |
| K001370 | ACCUSONIC PLUS, MODEL AP-100 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | 2000-07-17 |
| K001296 | SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM | Cavendish Scott, Inc. | ITH | Class II | 2000-07-17 |
| K001401 | AMT THERAPEUTIC TABLE, MODEL 748AMT | Amt Mfg., Inc. | ITH | Class II | 2000-07-12 |
| K001166 | ULTRA V THERAPEUTIC ULTRASOUND | Excel Tech. , Ltd. | IMG | Class II | 2000-07-07 |
| K001252 | MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 | Maxhealth Corp. | IOR | Class I | 2000-06-12 |
| K000738 | WHEELCHAIR, MODELS H001A, 4422 | Jackson Company, LLC | IOR | Class I | 2000-05-26 |
| K000604 | NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT | Naturopathic Laboratories International, Inc. | IMI | Class II | 2000-05-23 |
| K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) | Neurosoft, Inc. | IKN | Class II | 2000-05-17 |
| K001079 | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO | Arjo, Inc. | ILJ | Class II | 2000-05-01 |
| K994062 | HMS NEUROMUSCULAR STIMULATOR | Home Medical Services, Inc. | IPF | Class II | 2000-04-10 |
| K994065 | MS-ONE, MODEL MS-1 | Home Wellness West | IPF | Class II | 2000-04-04 |
| K000497 | VOYAGER/VIPER WHEELCHAIR | Otto Bock Orthopedic Industry, Inc. | IOR | Class I | 2000-03-08 |
| K994057 | SLENDAIR 4000 COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | IRP | Class II | 2000-03-03 |
| K993081 | IO-DRIVE | Selectivemed Components, Inc. | EGJ | Class II | 2000-03-03 |
| K000602 | PROTEGE WHEELCHAIR | Otto Bock Orthopedic Industry, Inc. | IOR | Class I | 2000-03-03 |
| K000220 | MA-300 ELECTROMYOGRAPHY SYSTEM | Motion Lab Systems, Inc. | IKN | Class II | 2000-02-24 |
| K000174 | ACTION AF-1 WHEELCHAIR | Invacare Corp. | IOR | Class I | 2000-02-18 |
| K984565 | TMC-EASY-302 | Tmc Magnetics & Machinery Corp. | INI | Class II | 2000-02-16 |
| K993872 | VANNA BATHING SYSTEM | Vancare, Inc. | ILJ | Class II | 2000-02-16 |
| K992828 | E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER | Accelerated Rehab Designs, Inc. | ITI | Class II | 2000-02-03 |
| K994127 | GLORY | Pillar Technology, Inc. | INI | Class II | 2000-02-03 |
| K992804 | T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER | Accelerated Rehab Designs, Inc. | ITI | Class II | 2000-02-03 |
| K992708 | IONTOPATCH | Birch Point Medical, Inc. | EGJ | Class II | 2000-02-01 |
| K993878 | JE 2000 | Jack'S Electrodes | IKN | Class II | 2000-02-01 |
| K990445 | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | Lpg USA, Inc. | ISA | Class I | 2000-01-18 |
| K993963 | SIGMA MANUAL WHEELCHAIR | Sigma Distribution & Supply, Inc. | IOR | Class I | 2000-01-13 |
| K994241 | TRX-CG POWER TILT AND RECLINE SYSTEM | Motion Concepts | ITI | Class II | 2000-01-13 |
| K994185 | MANUAL WHEELCHAIR | Major Mobility Products, Inc. | IOR | Class I | 2000-01-13 |
| K994072 | AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM | Amylior, Inc. | ITI | Class II | 2000-01-13 |
| K992779 | A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM | Medi-Man Rehabilitation Products, Inc. | ILJ | Class II | 2000-01-13 |
| K994107 | AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS. | Amylior, Inc. | ITI | Class II | 2000-01-13 |
| K993461 | QUEST INTERSEGMENTAL ROLLER TRACTION TABLE | Icon Intl., LLC | JFB | Class II | 2000-01-03 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.