Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 21
- Latest Decision
- 2002-02-01
Clearances · page 22 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K014198 | BIOTECH B990K VIVI WHEELCHAIR | Taiwan Armada Enterprise Co., Ltd. | IOR | Class I | 2002-02-01 |
| K013707 | SOFTIQUE, MODEL GI 11001 | Global TV Concepts, Ltd. | IMC | Class II | 2002-02-01 |
| K013927 | MINI SHOPPER | Shoprider Intl., Inc. | INI | Class II | 2002-01-28 |
| K992099 | BIO SPA INTELLIGENT | Starbene | IPF | Class II | 2002-01-18 |
| K013771 | MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE | Rich-Mar Corp. | IPF | Class II | 2002-01-18 |
| K011846 | BIOTECH POWERED WHEELCHAIR, C650PW | Roc Chinese-European Industrial Research Society | ITI | Class II | 2002-01-18 |
| K013770 | MODIFICATION TO: WINNER ST-2 STIMULATOR | Rich-Mar Corp. | IPF | Class II | 2002-01-18 |
| K011355 | BIOLIGHT PCD | Biolight International AB | ILY | Class II | 2002-01-17 |
| K012580 | ERCHONIA PL2000 | Tuco Innovations, Inc. | NHN | Class II | 2002-01-17 |
| K013094 | ORTHOSONIX ENERGEX | Orthosonix, Inc. | NHH | Class II | 2001-12-14 |
| K013516 | INVACARE ELEVATING SEAT OPTION ESS6 | Invacare Corp. | ITI | Class II | 2001-12-13 |
| K013788 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 | Merits Health Products Co., Ltd. | INI | Class II | 2001-12-11 |
| K013761 | MEDLINE EXCEL RECLINCER WHEELCHAIR | Medline Industries, Inc. | IOR | Class I | 2001-12-06 |
| K012258 | COMPANION MODEL 221, 321, 421 | Golden Technologies, Inc. | INI | Class II | 2001-12-03 |
| K013328 | REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 | Remington Products Company, LLC | IMC | Class II | 2001-12-03 |
| K013081 | MEDSTAR 150 | Mednet Services, Inc. | IPF | Class II | 2001-11-20 |
| K012846 | ZIPPY, MODEL I88WA | Pillar Technology, Inc. | ITI | Class II | 2001-11-20 |
| K011473 | SNAZZY2 | Shoprider Intl., Inc. | INI | Class II | 2001-11-16 |
| K012885 | NEUROMOVE NM900 | Dan Med, Inc. | IPF | Class II | 2001-11-08 |
| K011476 | SOVEREIGN | Shoprider Intl., Inc. | INI | Class II | 2001-10-30 |
| K011913 | SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES | Sun-Rain System Corp. | IPF | Class II | 2001-10-26 |
| K000741 | EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188 | 138 Medical Supplies, Inc. | IPF | Class II | 2001-10-24 |
| K012909 | XTERRA GT POWER WHEELCHAIR | Invacare Corp. | ITI | Class II | 2001-10-24 |
| K012791 | C.T.M. MOBILITY SCOOTER MODEL # HS-320 | Warepalmy Enterprise, LLC (Usa) | INI | Class II | 2001-10-24 |
| K012792 | C.T.M. MOBITIY SCOOTER MODEL #HS-360 | Warepalmy Enterprise, LLC (Usa) | INI | Class II | 2001-10-24 |
| K013192 | SONICATOR PLUS 930, MODEL ME 930 | Mettler Electronics Corp. | IMI | Class II | 2001-10-17 |
| K011530 | VERTRAN STANDING WHEELCHAIR | Fena Design, Inc. | IPL | Class II | 2001-10-16 |
| K012508 | MU PHOTONICS PAIN THERAPIST | Nu Photonics, Inc. | ILY | Class II | 2001-10-09 |
| K012345 | NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR | Bromac Assistive Technology | IPL | Class II | 2001-10-03 |
| K012592 | EASYTRAVEL | Tzora Active Systems , Ltd. | INI | Class II | 2001-10-03 |
| K010749 | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL | Biomedical Life Systems, Inc. | IPF | Class II | 2001-09-28 |
| K010335 | SLENDERTONE FLEX, MODEL, 512 | Bio-Medical Research, Ltd. | NGX | Class II | 2001-09-27 |
| K012927 | M71 POWER WHEELCHAIR | Invacare Corp. | ITI | Class II | 2001-09-19 |
| K012802 | MP3CF ELECTRIC WHEELCHAIR | Merits Health Products., Inc. | ITI | Class II | 2001-09-18 |
| K011818 | STERILE EMG ELECTRODES | Nicolet Biomedical, Inc. | IKT | Class II | 2001-09-06 |
| K002908 | JET THERAPY | Jet Therapy | ISA | Class I | 2001-08-30 |
| K011745 | HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR | Transworld Mobility Distribution, LLC | ITI | Class II | 2001-08-30 |
| K002339 | AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600 | Apex Medical Corp. | IPF | Class II | 2001-08-24 |
| K011744 | HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR | Transworld Mobility Distribution, LLC | ITI | Class II | 2001-08-24 |
| K002992 | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 | Medtronic Functional Diagnostics A/S | IKT | Class II | 2001-08-15 |
| K011513 | MP3U, POWER WHEELCHAIR | Merits Health Products., Inc. | ITI | Class II | 2001-08-10 |
| K010702 | XUB EXTERNAL ULTRASOUND | Kmi Kolster Methods, Inc. | IMI | Class II | 2001-08-09 |
| K010807 | MUSCLE STIMULATOR SA-100 | Health@Fitness Technologies, Inc. | IPF | Class II | 2001-08-09 |
| K011751 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 | Merits Health Products., Inc. | INI | Class II | 2001-08-06 |
| K012370 | SOLARA JR. MANUAL WHEELCHAIR | Invacare Corp. | IOR | Class I | 2001-08-03 |
| K011707 | TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 | Merits Medical Industries Co., Ltd. | INI | Class II | 2001-08-03 |
| K011753 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 | Merits Health Products., Inc. | INI | Class II | 2001-08-03 |
| K011687 | MP-3C POWER BASE CHAIR, MODEL MP3C | Merits Health Products., Inc. | ITI | Class II | 2001-08-03 |
| K011768 | THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 | Thermo-Electric Co. | LSB | Class II | 2001-08-03 |
| K012281 | TRS-2000 POWER TILT/POWER RECLINE SYSTEM | Accelerated Rehab Designs, Inc. | ITI | Class II | 2001-08-01 |
| K012167 | MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR | Invacare Corp. | IOR | Class I | 2001-08-01 |
| K002336 | MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T | Apex Medical Corp. | IPF | Class II | 2001-07-27 |
| K012061 | SUPERIOR BATH, MODEL 6300 | Penner Manufacturing, Inc. | ILJ | Class II | 2001-07-19 |
| K012057 | CASCADE BATH, MODEL 6900 | Penner Manufacturing, Inc. | ILJ | Class II | 2001-07-19 |
| K011955 | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | 2001-07-16 |
| K010600 | SUPREMA POWERED WHEELCHAIR | Luigi Chinetti | ITI | Class II | 2001-07-13 |
| K011993 | QUANTUM BLAST | Pride Mobility Products Corp. | ITI | Class II | 2001-07-13 |
| K011401 | RAMBLER | Rambler Mobility, Inc. | INI | Class II | 2001-07-13 |
| K010503 | AMIGO WHEELCHAIR | Amigo Mobility Intl., Inc. | INI | Class II | 2001-07-06 |
| K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | Chattanooga Group, Inc. | LSB | Class II | 2001-07-06 |
| K002580 | PRAIRIE CRUISER | Raye'S, Inc. | ITI | Class II | 2001-07-03 |
| K011752 | GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY | Accufast, Inc. | IOR | Class I | 2001-06-28 |
| K010590 | NEUROPACK MICRO, MODEL MED-9100A SERIES | Nihon Kohden America, Inc. | IKN | Class II | 2001-06-28 |
| K010745 | EMS 3000 | Dan Med, Inc. | IPF | Class II | 2001-06-27 |
| K010941 | THE NIMBLE ROCKET POWERED WHEELCHAIR | Nimble, Inc. | ITI | Class II | 2001-06-22 |
| K011701 | BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR | Taiwan Armada Enterprise Co., Ltd. | IOR | Class I | 2001-06-22 |
| K003433 | NEURO-TRAIN III (3) | Sterne Equipment Co., Ltd. | IPF | Class II | 2001-06-15 |
| K003909 | PROACT 1 | Proact Co. | IRP | Class II | 2001-06-13 |
| K003596 | SMITH & NEPHEW RESTIM | Smith & Nephew, Inc. | IPF | Class II | 2001-06-06 |
| K002410 | FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE | Dysphagia, LLC | IPF | Class II | 2001-06-06 |
| K003538 | TDP CQ-27 HEAT LAMP | Lhasa Medical, Inc. | ILY | Class II | 2001-06-04 |
| K011374 | JEWEL MPS | Vestil Manufacturing Corp. | IOR | Class I | 2001-05-29 |
| K002058 | VECTORSURGE 5, MODEL VS-500 | Metron Medical Australia, Pty, Ltd. | IPF | Class II | 2001-05-29 |
| K011153 | ALANTE, BATTERY OPERATED POWER WHEELCHAIR | Golden Technologies, Inc. | ITI | Class II | 2001-05-29 |
| K011268 | BREEZY WHEELCHAIR, MODEL 300 | Sunrise Medical, Inc. | IOR | Class I | 2001-05-15 |
| K010917 | POWER TILT AND RECLINE SYSTEM | Sunrise Medical, Inc. | ITI | Class II | 2001-05-15 |
| K011107 | MODIFICATION TO SOLO | Ranger All Season Corp. | INI | Class II | 2001-05-14 |
| K010395 | E-POWER | Dalton Medical Corp. | ITI | Class II | 2001-05-11 |
| K011006 | AMYSEAT TILT/RECLINE SEATING | Amysystems | ITI | Class II | 2001-05-11 |
| K011227 | REGAL MOTOTRIZED 3 WHEELED VEHICLE | Bruno Independent Living Aids, Inc. | ITI | Class II | 2001-05-11 |
| K010380 | MP3HD BIG BOY, POWER WHEELCHAIR | Merits Health Products., Inc. | ITI | Class II | 2001-05-09 |
| K010292 | DRX 2000 | Axiom Worldwide, Inc. | ITH | Class II | 2001-05-01 |
| K010665 | TRANSAMERICA DIGITAL EMS | Transamerica Medical Systems | IPF | Class II | 2001-04-27 |
| K010823 | SPAZZ | Colours 'N Motion | IOR | Class I | 2001-04-27 |
| K010252 | MAGNUM | Magnum Equipment LLC | JFB | Class II | 2001-04-26 |
| K011053 | OPTIMA | Medical Industries America, Inc. | ITI | Class II | 2001-04-20 |
| K010859 | THE LIBERATOR WHEELCHAIR | Liberator Wheelchairs, Inc. | ITI | Class II | 2001-04-05 |
| K994083 | STANNAH POWER CHAIR, MODEL 201 | Stannah Power Chairs , Ltd. | IPL | Class II | 2001-04-04 |
| K003272 | FLO-BOOT | Discovery Group, LLC | BXB | Class I | 2001-04-04 |
| K000655 | PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE | Ahava Stein | IRP | Class II | 2001-03-26 |
| K010364 | MCC-MIV ONE 2 ONE SOFTWARE | Invacare Corp. | ITI | Class II | 2001-03-22 |
| K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | Wescor, Inc. | KTB | Class II | 2001-03-20 |
| K010609 | ACCUSONIC, MODEL AS-260 | Metron Medical Australia, Pty, Ltd. | IMI | Class II | 2001-03-16 |
| K010606 | SAFARI | Ranger All Season Corp. | INI | Class II | 2001-03-16 |
| K003449 | E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS) | Ulrich Alber GmbH & Co. | ITI | Class II | 2001-03-16 |
| K003058 | LASER 3 SPSC300 | Pride Mobility Products Corp. | INI | Class II | 2001-03-08 |
| K003059 | LASER 4SPSC340 | Pride Mobility Products Corp. | INI | Class II | 2001-03-01 |
| K003260 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 | Metron Medical Australia, Pty, Ltd. | IPF | Class II | 2001-02-22 |
| K010135 | MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4 | Invacare Corp. | INI | Class II | 2001-02-16 |
| K010194 | COMFOR-CLINER | Recliner Care, Inc. | IOR | Class I | 2001-02-15 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.