meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
25
Latest Decision
2002-12-02

Clearances · page 21 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K020130 ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M Rolor Electronics Corp. IPF Class II 2002-12-02
K022518 J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT Roc Chinese-European Industrial Research Society INI Class II 2002-12-02
K022993 HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS Hoveround Corp. ITI Class II 2002-12-02
K023581 COMFORT AGILE SCOOTER, LY-EW303 Comfort Orthopedic Co., Ltd. INI Class II 2002-12-02
K022652 ALPHATRAC, MODEL A 205 Teftec Corp. ITI Class II 2002-11-21
K023426 TRX VERTICAL POSITIONER Motion Concepts ITI Class II 2002-11-21
K023521 EASY LIFE Berkline Corp. INO Class II 2002-11-19
K023589 STORM TDX POWER WHEELCHAIR Invacare Corp. ITI Class II 2002-11-19
K022539 PHFW-10 Pihsiang Machinery Mfg. Co., Ltd. ITI Class II 2002-11-19
K023606 TILITE YG AND TILITE YGS Tisport IOR Class I 2002-11-19
K023282 ORS-3000LD O.R. Solutions, Inc. LHC Class I 2002-11-13
K022719 PHYSICAL MONITORING REGISTRATION UNIT Maryrose Cusimano, Ph.D./Phil Reaston IKN Class II 2002-11-13
K023283 1075LD HUSH-SLUSH O.R. Solutions, Inc. LHC Class I 2002-11-13
K021925 SUNPEX TECHNOLOGIES MODEL SE 01 Sunpex Technology Co., Ltd. INI Class II 2002-11-08
K022309 STRYKER POWERED WHEELED STRETCHER Stryker Corp. INK Class II 2002-11-08
K020750 DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS Everyway Medical Instruments Co.,Ltd IPF Class II 2002-10-31
K022626 MOISTURESTAY (REVLON) Raymond Industrial, Ltd. IMC Class II 2002-10-29
K022194 TRAXX ELECTRIC WHEELCHAIR Crossroads Distribution Company, LLC ITI Class II 2002-10-29
K023005 AQUILLA MODULAR WHEELCHAIR Haywood Vocational Opportunities IOR Class I 2002-10-18
K022924 SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR) Otto Back Healthcare, LP IOR Class I 2002-10-17
K022493 EMS 400 Body Clock Health Care, Ltd. IPF Class II 2002-10-11
K022369 COMFORT WINDJOY SCOOTER, MODEL LY-EW302 Comfort Orthopedic Co., Ltd. INI Class II 2002-10-11
K021910 COMFORT DREAMRIDER SCOOTER, LY-EW402 Comfort Orthopedic Co., Ltd. INI Class II 2002-10-11
K022458 AUTO*THERM 395, MODEL ME 395 Mettler Electronics Corp. IMJ Class II 2002-09-26
K020851 TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D C&H International ILY Class II 2002-09-23
K020464 SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 Rolor Electronics Corp. ILY Class II 2002-09-17
K020462 SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 Rolor Electronics Corp. ILY Class II 2002-09-16
K021483 RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND Rich-Mar Corp. IMI Class II 2002-09-13
K020427 AB BELT The Dezac Group NGX Class II 2002-09-13
K022699 TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR Forever Young Ent. Co., Ltd. IOR Class I 2002-09-13
K022617 COMFY HIGH RISER WHEELCHAIR Lenjoy Medical Engineering, Inc. IOR Class I 2002-09-13
K020429 AB BELT PRO The Dezac Group NGX Class II 2002-09-13
K022825 MANUAL WHEELCHAIR Major Mobility Products, Inc. IOR Class I 2002-09-13
K022700 DELUXE MANUAL WHEELCHAIR HW 4000 Forever Young Ent. Co., Ltd. IOR Class I 2002-09-13
K022776 NESS SYSTEM Ness-Neuromuscular Electrical Stimulation Systems IPF Class II 2002-09-11
K021985 MEDX LCS LASER SERIES Medx Electronics, Inc. NHN Class II 2002-09-10
K022175 P4 PHYSIO Valmed Corp. IPF Class II 2002-09-09
K021905 CLASSIC NMS Care Rehab, Inc. IPF Class II 2002-09-05
K021843 EYEFEEL OPHTHALMIC WARMER Bio-Lipid, Inc. IMD Class I 2002-09-03
K013197 WS-501 HEAT LAMP Lhasa Medical, Inc. ILY Class II 2002-08-29
K022704 TAILWIND Deltaglide ITI Class II 2002-08-27
K022407 MULTI FUCTIONAL REHABILITATION CHAIR Raye'S, Inc. INO Class II 2002-08-16
K022509 BRUNO ELECTRA-RIDE, MODEL SRE-2700 Bruno Independent Living Aids, Inc. ILK Class II 2002-08-13
K021956 MHS MED LIGHT 1000 Micro Health Systems, Inc. ILY Class II 2002-08-13
K003128 MODIFICATION TO RELIEF BRIEF The JM Kohn Co. NJB Class I 2002-08-12
K022404 ACTIBAND Paw, LLC ILX Class II 2002-08-08
K021472 HMS-DHR-3 NEUROMUSCULAR STIMULATOR Home Medical Services IPF Class II 2002-08-06
K021617 C.T.M. POWER CHAIR, MODEL HS-2800 C.T.M. Homecare Product, Inc. ITI Class II 2002-08-02
K021995 ESCAPE CONTROL MODULE Specialty Drives Technologies, Inc. ITI Class II 2002-08-01
K020227 SELICOR, MODELS A100 & D100 Selicor, Inc. IMJ Class II 2002-07-30
K013763 WU'S 4-WHEELED NEO SCOOTER, WT-L4 Wu'S Tech Co., Ltd. INI Class II 2002-07-30
K021264 TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT Motion Concepts ITI Class II 2002-07-30
K020657 ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE Acculaser, Inc. NHN Class II 2002-07-29
K014119 WU'S 3-WHEELED NEO SCOOTER, WT-M3 Wu'S Tech Co., Ltd. INI Class II 2002-07-25
K020119 VECTORSONIC, MODEL VU-200 Metron Medical Australia, Pty, Ltd. IMG Class II 2002-07-22
K021592 PHFW-10 Pihsiang Machinery Mfg. Co., Ltd. ITI Class II 2002-07-15
K020017 MEDX 1000 SERIES Medx Electronics, Inc. ILY Class II 2002-07-12
K021199 PRIMECHAIR Dalton Medical Corp. ITI Class II 2002-07-12
K021075 MECHANICAL DAILY USE WHEELCHAIR First World Services, Inc. IOR Class I 2002-07-12
K014019 NEUROTECH MEDISTIM PLUS, TYPE 291 Bio-Medical Research, Ltd. IPF Class II 2002-07-11
K013768 POWERED MUSCLE STIMULATOR Theratech, Inc. IPF Class II 2002-07-03
K014208 SSIR SYSTEM Russian-American Technology Associates, Inc. ILY Class II 2002-07-02
K021165 NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES Bromac Assistive Technology IPL Class II 2002-07-01
K013061 BIOTOUCH MASSAGE THERAPY SYSTEM Tactile Systems Technology, Inc. IRP Class II 2002-07-01
K021754 APEX MEDICAL DIGITAL EMS TS1311, TS1312 Apex Medical Corp. IPF Class II 2002-06-28
K021288 ORS-1000LD O.R. Solutions, Inc. LHC Class I 2002-06-27
K021289 WARMER 2000LD O.R. Solutions, Inc. LHC Class I 2002-06-26
K020539 TIPOWER POWERDRIVE AND RIMPOWER X & SX Tisport ITI Class II 2002-06-20
K020639 TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER Tisport ITI Class II 2002-06-20
K021680 INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 Invacare Corp. ITI Class II 2002-06-18
K021100 300 PV COMPLETE ELECTROTHERAPY SYSTEM Empi IPF Class II 2002-06-18
K020907 NEUROLINE, SUBDERMAL NEEDLE ELECTRODES Medicotest A/S IKT Class II 2002-06-14
K021866 KARMA 800 SERIES MANUAL WHEELCHAIR Vestil Manufacturing Corp. IOR Class I 2002-06-14
K021763 RS2MI MUSCLE STIMULATOR FAMILY Rs Medical IPF Class II 2002-06-13
K020637 SELECT STIM Care Rehab and Orthopaedic IPF Class II 2002-05-28
K020684 FINESUN EMS STIMULATOR Finesun Worldwide Intl. Co., Ltd. IPF Class II 2002-05-23
K021371 SUNSPEX TECHNOLOGIES MODEL SE 02 Sunpex Technology Co., Ltd. INI Class II 2002-05-16
K021145 ACCOMMODATOR WHEELCHAIR, MODEL #2000X Marken International, Inc. IOR Class I 2002-05-16
K020476 MEDION 6000 Selectivemed Components, Inc. EGJ Class II 2002-05-03
K021255 Y.E.S 10 WHEELCHAIR Movingpeople.Net ITI Class II 2002-05-02
K020314 DIGI-PRO TENS, MODEL WL-2204 AND WL-2205 Well-Life Healthcare, Inc. IPF Class II 2002-04-30
K021136 TEKNIQUE-HOVEROUND POWER WHEEL CHAIR Hoveround Corp. ITI Class II 2002-04-19
K011880 COMPEX SPORT Compex S.A. NGX Class II 2002-04-17
K003916 DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM Scandia Manufacturing , Ltd. IMB Class II 2002-04-15
K020933 GARAVENTA SUPER-TRAC TRE-52 Garaventa Accessibility ING Class II 2002-04-04
K011588 SURETONE Suretone International IPF Class II 2002-03-28
K020001 PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 Transworld Mobility Distribution, LLC INI Class II 2002-03-21
K020737 CAT ACTIVE WHEELCHAIR Movingpeople.Net IOR Class I 2002-03-21
K020002 MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33 Transworld Mobility Distribution, LLC INI Class II 2002-03-21
K020536 GAZELLE WHEELCHAIR Alum Creek Wheelchair Co., Inc. IOR Class I 2002-03-15
K014127 KARMA DISCOVERY, MODEL KP40 Vestil Manufacturing Corp. ITI Class II 2002-03-15
K020451 COMFORT WHEELCHAIRS Comfort Orthopedic Co., Ltd. IOR Class I 2002-03-14
K020188 BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR Taiwan Armada Enterprise Co., Ltd. IOR Class I 2002-03-08
K020094 EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS Regulatory Insight, Inc. IOR Class I 2002-03-08
K020100 SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS Regulatory Insight, Inc. IOR Class I 2002-03-08
K020472 BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR Taiwan Armada Enterprise Co., Ltd. IOR Class I 2002-03-08
K013361 WIN-2 TANGO ELITE NP Durable Medical Equipment, Inc. ITI Class II 2002-02-26
K013307 OMEGATRAC, MODEL Z105 Teftec Corp. ITI Class II 2002-02-08
K020284 BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR Taiwan Armada Enterprise Co., Ltd. IOR Class I 2002-02-08
K010175 MICROLIGHT 830 LASER SYSTEM Microlight Corporation of America NHN Class II 2002-02-06

5,661 clearances in the Physical Medicine panel. Data: openFDA.