meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
24
Latest Decision
2000-01-03

Clearances · page 24 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993919 DYNATRON 900 Dynatronics Corp. ITH Class II 2000-01-03
K991835 HANG UPS POWER II Stl Intl., Inc. ITH Class II 1999-12-20
K993443 RTD ARM ASSISTIVE ROBOTIC DEVICE Rehabilitation Technologies Division ITI Class II 1999-12-17
K993123 QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B United Pacific Co., Ltd. ILY Class II 1999-12-17
K993413 STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL Invacare Corp. ITI Class II 1999-12-15
K993821 VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT Metron Medical Australia, Pty, Ltd. IPF Class II 1999-12-09
K993160 OMEGA TRAC, MODEL Z100 Teftec Corp. ITI Class II 1999-11-18
K992874 Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM Wr Medical Electronics Co. KTB Class II 1999-11-18
K993640 SPECTRUM LIBRE WHEELCHAIR Freedom Designs, Inc. IOR Class I 1999-11-16
K993298 E Z CHAIR Premier Designs IOR Class I 1999-11-16
K992733 AKRON ATP9 TRACTION MACHINE Huntleigh Technology, Inc. ITH Class II 1999-11-10
K993032 MODIFICATION TO MP-3 POWER BASE CHAIR Merits Health Products., Inc. ITI Class II 1999-11-05
K991954 THE BRUNO POWERBASE, MODEL PSB-2200 Bruno Independent Living Aids, Inc. ITI Class II 1999-11-02
K992884 WHEELCHAIR (MANUAL, NOT ELECTRICAL) Foshan Machinery & Equipment Import & Export Co. IOR Class I 1999-11-02
K992310 TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4. Rupiani Medical IOR Class I 1999-11-02
K991241 IF8000 Dan Med, Inc. IPF Class II 1999-11-02
K990233 ST-302 INFRAREX Skylark Device Co., Ltd. ILY Class II 1999-10-27
K991281 ELECTRIC MOBILITY CAVALIER SCOOTERS Electric Mobility, LLC INI Class II 1999-10-27
K992627 FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500 Teftec Corp. ITI Class II 1999-10-25
K992628 FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400 Teftec Corp. ITI Class II 1999-10-25
K992619 AMIGO MODEL 680000 (AMIGO EXCITE F 350) Amigo Mobility Intl., Inc. ITI Class II 1999-10-25
K991132 ACTIVA Hoveround Corp. INI Class II 1999-10-20
K990787 TRIO 300 Ito Co., Ltd. IPF Class II 1999-10-20
K983808 ZIPPY Pillar Technology, Inc. ITI Class II 1999-10-14
K992372 THE LEADAWAY Therapy Equipment, Inc. IKD Class II 1999-10-13
K991658 PERMOBIL POWERED WHEELCHAIR 1280 Permobil AB ITI Class II 1999-10-08
K991090 PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3) Dynamic Systems, Inc. ITI Class II 1999-09-24
K992694 MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I Myotronics-Noromed, Inc. KZM Class II 1999-09-10
K991991 DUPEL IONTOPHORESIS SYSTEM Empi EGJ Class II 1999-09-10
K984391 THE LIBERATOR Liberator Wheelchairs, Inc. IPL Class II 1999-09-03
K992545 TM-300 TRACTION SYSTEM Ito Co., Ltd. ITH Class II 1999-09-01
K990766 CERSR ELECTROMYOGRAPHY SYSTEM Paraspinal Diagnostic Corp. IKN Class II 1999-08-27
K991119 TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G Invacare Corp. ITI Class II 1999-08-19
K991693 TWO RIVERS POWER LIFT/RECLINE CHAIR Two Rivers, LLC INO Class II 1999-08-17
K991427 PARAMED PARAFFIN WARMER Divi Intl. Co. IMC Class II 1999-08-13
K991921 INTERMITTENT COMPRESSION BOOT FOR OTC Eischoco, Inc. IRP Class II 1999-08-13
K982724 THERADYNE ROVER POWERED WHEELCHAIR Kurt Mfg. Co. ITI Class II 1999-08-12
K991931 CTD MARK I TRACTION DEVICE Therasys, Inc. ITH Class II 1999-08-12
K992035 MANUAL WHEELCHAIR Major Mobility Products, Inc. IOR Class I 1999-08-12
K992052 MODELS LYNX AND PANTHER MOTORIZED SCOOTERS Invacare Corp. INI Class II 1999-08-12
K991503 SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 United Pacific Co., Ltd. ILY Class II 1999-07-28
K991590 C-LEG (3C100) Otto Bock Orthopedic Industry, Inc. ISW Class II 1999-07-08
K983497 OVERLANDER PEV 2000 Raye'S, Inc. ITI Class II 1999-06-27
K990122 INDEPENDENCE 624 Eagle Parts & Products, Inc. ITI Class II 1999-06-25
K991168 ARROW FWD POWER WHEELCHAIR Invacare Corp. ITI Class II 1999-06-25
K990484 INDEPENDENCE 324 Eagle Parts & Products, Inc. ITI Class II 1999-06-25
K991184 HYDROTONE-THERMAL CAPSULE SYSTEM Nats Corp. ILJ Class II 1999-06-23
K991313 ACCUTRED SHOE Orthopedic Technology Research, Inc. IRN Class II 1999-06-23
K982950 FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 Chalgren Enterprises, Inc. IKT Class II 1999-06-22
K990697 RS-4V MUSCLE STIMULATOR Rs Medical IPF Class II 1999-06-18
K983987 AMIGO MODEL 590000 Amigo Mobility Intl., Inc. INI Class II 1999-06-08
K990015 ELECTRODE NEEDLES Technomed Europe IKT Class II 1999-05-27
K984052 SYNERGY IOM SYSTEM Oxford Instruments Medical Systems IKN Class II 1999-05-17
K990139 KENSTONE Kenda USA IOR Class I 1999-04-29
K990866 QUINTON MEDTRACK CR PLUS TREADMILL Quinton, Inc. ISD Class II 1999-04-29
K982145 MEGA 3 Mega Motion, Inc. INI Class II 1999-04-14
K982144 MEGA 4 Mega Motion, Inc. INI Class II 1999-04-14
K990813 REHCOR Electromed Corp. ISD Class II 1999-04-12
K990544 TRX-CG POWER TILT AND RECLINE SYSTEM Motion Concepts ITI Class II 1999-04-08
K990555 TISPORT X AND TISPORT XC Tisport IOR Class I 1999-03-22
K990557 THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR Pdg Product Design Group, Inc. IOR Class I 1999-03-22
K990463 MEDLINE EXCEL WHEELCHAIRS Medline IOR Class I 1999-03-15
K990375 DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 Medtronic Functional Diagnostics A/S IKT Class II 1999-03-09
K982668 PHORESOR II,MODEL PM900 Iomed, Inc. EGJ Class II 1999-03-02
K990358 CROSS SPORT, RIGID WHEELCHAIR Tisport IOR Class I 1999-02-26
K984199 EXONIX Fibra Sonics, Inc. IMI Class II 1999-02-17
K984114 SYS STIM 294, MODEL ME 294 Mettler Electronics Corp. IPF Class II 1999-02-09
K984142 SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994 Mettler Electronics Corp. IPF Class II 1999-02-09
K990157 MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIR Invacare Corp. IOR Class I 1999-02-03
K982750 CORSAIRE Optiway, Inc. ITI Class II 1999-02-01
K982317 VECTRA COMBO Chattanooga Group, Inc. IMG Class II 1999-02-01
K984367 ACTIVX Adorno Rogers Technology IOR Class I 1999-01-28
K984113 MS400 Lsi Intl., Inc. IPF Class II 1999-01-28
K984021 MS300 Lsi Intl., Inc. IPF Class II 1999-01-28
K984354 MECHANICAL WHEELCHAIR Colours 'N Motion IOR Class I 1999-01-28
K982652 ALLEGIANCE PORTA-WARM MATTRESS Allegiance Healthcare Corp. IMD Class I 1999-01-21
K984457 WORLD CLASS WHEELED CHAIR, MODEL SS Suiter Medical LLC IOR Class I 1999-01-19
K984447 MODEL ACTION AT II MANUAL WHEELCHAIR Invacare Corp. IOR Class I 1999-01-08
K984493 MAXXIM; MAXXIM HD Major Mobility Products, Inc. IOR Class I 1999-01-08
K983484 DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE Empi EGJ Class II 1998-12-28
K983663 C.T.M. MOBILITY SCOOTER, MODEL # HS-666 Warepalmy Enterprise, LLC (Usa) INI Class II 1998-12-18
K983662 C.T.M. MOBILITY SCOOTER, MODEL # HS-686 Warepalmy Enterprise, LLC (Usa) INI Class II 1998-12-18
K983526 VERTICAL LIFT Barnes,Richardson & Colburn ING Class II 1998-12-11
K981449 SD-956 ULTRASOUND THERAPY Skylark Device Co., Ltd. IMI Class II 1998-12-11
K983066 FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300 Teftec Corp. ITI Class II 1998-11-27
K983681 DOMINATOR Impact Wheelchair Manufacture, Inc. IOR Class I 1998-11-27
K983859 SPECTRUM SMALL FRY Freedom Designs, Inc. IOR Class I 1998-11-25
K983763 SPECTRUM SPIRIT Freedom Designs, Inc. IOR Class I 1998-11-23
K982544 RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES Rich-Mar Corp. IMI Class II 1998-11-19
K981885 SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE Sunrise Medical, Inc. INI Class II 1998-11-12
K982830 FORTE, MODELS CPS 400 COMBO, CPS 200 COMBO Chattanooga Group, Inc. IMG Class II 1998-11-06
K982829 FORTE, MODEL CPS ULTRASOUND Chattanooga Group, Inc. IMI Class II 1998-11-06
K983520 BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD Sunrise Medical, Inc. ITI Class II 1998-11-06
K982815 ALPHATRAC, MODEL A200 Teftec Corp. ITI Class II 1998-11-06
K983677 QUICKIE G SERIES, MODEL G-424 Sunrise Medical, Inc. ITI Class II 1998-11-06
K983405 ACEME JUPITER SCOOTER, 3-WHEELED, MODEL JUPITER 50 Aceme Technologies Intl. INI Class II 1998-11-06
K982828 FORTE, MODELS CPS 400 STIM, CPS 200 STIM Chattanooga Group, Inc. IPF Class II 1998-11-06
K983407 ACEME JUPITER SCOOTER, 4-WHEELED,MODEL JUPITER 50F Aceme Technologies Intl. INI Class II 1998-11-06
K981462 QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 Sunrise Medical, Inc. ITI Class II 1998-11-06
K982636 PATIENT WARMER- MODEL PW810 Fisher & Paykel Healthcare, Ltd. ILY Class II 1998-10-26

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