meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
33
Latest Decision
1996-09-16

Clearances · page 27 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K954427 HELPING HAND Kinetic Rehabilitation Instruments, Inc. ITI Class II 1996-09-16
K960457 ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C Med Labs, Inc. IPF Class II 1996-09-06
K955788 IMNI HOT PACKS Omni Therm, Inc. IMD Class I 1996-09-04
K961176 OMNI COLD GEL PACKS Omni Therm, Inc. IMD Class I 1996-09-04
K950025 SELF PROPELLED ROBOTIC WHEEL (SPRW) Datatran, Inc. ITI Class II 1996-09-03
K961250 DYNATRON 125 ULTRASOUND Dynatronics Corp. IMI Class II 1996-08-26
K951033 ANDELA DYNAMIC COOLING DEVICE Candela Laser Corp. IMD Class I 1996-08-15
K952163 DAVID BACK CLINIC SYSTEM Kinetic Resources, Inc. ISD Class II 1996-08-12
K961855 POLAR CARE (MODEL 500/50000) Breg, Inc. ILO Class II 1996-08-09
K961744 TK40 - TILTMASTER Mechanical Application Designs, Inc. ITI Class II 1996-07-25
K954378 FORMULA IV ELECTRIC MOBILITY VEHICLE Aerotek INI Class II 1996-07-25
K951622 VAX-D THERAPEUTIC TABLE Vat-Tech, Inc. ITH Class II 1996-07-02
K955240 OMEGATRAC BY TEFTEC Teftec Corp. ITI Class II 1996-07-01
K961306 DELTATALKER WITH INFRARED Prentke Romich Co. IQA Class II 1996-06-27
K960307 INDEX SHOE Orthopedic Technology Research, Inc. IRN Class II 1996-06-27
K960802 CUSHMAN MANUFACTURING, INC. ULTRA 6.0. Cushman Mfg., Inc. IMI Class II 1996-06-18
K960591 RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP Chalgren Enterprises, Inc. IKT Class II 1996-06-13
K955529 CRYTRON SYSTEM Mark H. Friedman ILO Class II 1996-06-10
K960036 FIRARD II/ TDP LAMP Helio Medical Supplies, Inc. ILY Class II 1996-06-06
K954131 HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND Hoveround Corp. ITI Class II 1996-06-06
K961154 BAXTER SODIUM ACETATE INFANT HEEL WARMER Baxter Healthcare Corp MPO Class I 1996-06-06
K961663 ELECTRIC SEAT LIFT CHAIR Ken Kemmerer INO Class II 1996-05-29
K961743 ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR Pdg Product Design Group, Inc. IOR Class I 1996-05-29
K945936 JAZZY Pride Health Care, Inc. ITI Class II 1996-05-28
K952273 HANDMASTER NMS1 Neuromusclar Electrical Stimulation Systems, Ltd. IPF Class II 1996-05-23
K955736 STIM-8 Bmr , Ltd. IPF Class II 1996-05-22
K960433 VST-10, VST-10/2 Vcare Intl., Inc. IPF Class II 1996-05-21
K955146 AXIOM-HVG Axiom Manufacturing IPF Class II 1996-05-17
K952675 ORTHOFAB WHEELCHAIR Orthofab, Inc. ITI Class II 1996-05-07
K961514 BCW ADVANTAGE WHEELCHAIR Wheelchairs of Kansas IOR Class I 1996-05-07
K960624 CERTI COOL INSTANT COLD COMPRESS Certified Safety Mfg., Inc. IMD Class I 1996-05-06
K941567 DIATHERMY DEVICE-MICROFOCUS Cheung Laboratories, Inc. IOA Class II 1996-04-22
K955034 FORCEGUARD Impact Monitors, Inc. IRN Class II 1996-04-10
K955326 SPORTS CONTRAST THERAPY SYSTEM ST 7000 Burke Neutech, Inc. ILO Class II 1996-04-10
K954135 POWERCHAIR Wheelcare Scooters, Inc. ITI Class II 1996-04-10
K953796 BANKS HYDRO-THERAPY CHAIR Keith Products, Inc. ILM Class II 1996-04-01
K960739 V-1504 VERTICAL PLATFORM LIFT Barnes,Richardson & Colburn ING Class II 1996-04-01
K954136 MATRIX MICROSON 410 Matrix Biokinetics, Inc. IMI Class II 1996-04-01
K954671 THE FREEDOM BED Probed Medical Technologies, Inc. IKZ Class II 1996-04-01
K960276 WHEELCHAIR ELEVATOR Services Industriels Savaria, Inc. ING Class II 1996-04-01
K960096 ULTRA III Excel Tech. , Ltd. IPF Class II 1996-03-27
K960489 ULTRA IV Excel Tech. , Ltd. IPF Class II 1996-03-27
K954974 PACE SAVER LITTLE JUNIOR (MODIFICATION) Burke Mobility Products INI Class II 1996-03-19
K955057 MODEL 1100 COLD THERAPY DEVICE Smith and Nephew Donjoy, Inc. ILO Class II 1996-03-08
K954095 MEDICOOL (MODIFICATON) Microclimate Systems, Inc. ILO Class II 1996-03-06
K952536 SONO 5 Zimmer Elektromedizin GmbH IMI Class II 1996-03-05
K952042 TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER Merits Health Products Co., Ltd. INI Class II 1996-03-04
K954411 GALVA-5-M Zimmer Elektromedizin GmbH IPF Class II 1996-02-28
K960402 BUDDY WHEELCHAIR Metro-Care IOR Class I 1996-02-16
K960336 CARDON PHYSICAL THERAPY TABLE MODEL R27645 Cardon Rehabilitation Products, Inc. INQ Class I 1996-02-13
K954877 OMNI COLD GEL PACKS Omni Therm, Inc. IMD Class I 1996-02-13
K960334 CARDON PHYSICAL THERAPY TABLE MODEL R27116 Cardon Rehabilitation Products, Inc. INQ Class I 1996-02-13
K960332 CARDON PHYSICAL THERAPY TABLE MODEL R28598 Cardon Rehabilitation Products, Inc. INQ Class I 1996-02-13
K944940 EURO SC500 Pride Health Care, Inc. INI Class II 1996-02-12
K955160 COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER Everapex Design & Marketing Corp. IRO Class I 1996-02-08
K955250 QI GONG MASSAGER East Health Development Group, Inc. IRO Class I 1996-02-08
K960189 GEL-T CUSHION Span-America Medical Systems, Inc. KIC Class I 1996-02-07
K960196 TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 Tri W-G, Inc. INQ Class I 1996-02-07
K936312 MANUAL MASSAGE ROLLER Mckenna & Cuneo LYG Class I 1996-01-29
K955335 DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE Chalgren Enterprises, Inc. IKT Class II 1996-01-29
K953456 E-Z FLEX Fluid Motion Biotechnologies, Inc. BXB Class I 1996-01-26
K954126 TRANSQ ELECTRODE PHORESOR II Iomed, Inc. KTB Class II 1996-01-19
K954716 DEROYAL INDUSTRIES INFANT HEEL WARMER Debusk Knitting Mills, Div. Deroyal Industries MPO Class I 1996-01-11
K955105 BTE CPM-10 Baltimore Therapeutic Equipment Co. BXB Class I 1995-12-29
K955106 BTE CPM-20 Baltimore Therapeutic Equipment Co. BXB Class I 1995-12-29
K946337 IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II Skylark Device Co., Ltd. EGJ Class II 1995-12-20
K954203 MASSAGER THERAPUTIC, ELECTRIC Cisco Sales Corp. IRO Class I 1995-12-11
K952090 HUMAC SYSTEM Computer Sports Medicine, Inc. IKK Class II 1995-12-11
K951028 HAMEX TWO Northern Orthopaedic Products, Inc. BXB Class I 1995-12-11
K951682 OCTOSTIM Freiler IPF Class II 1995-12-11
K953516 MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP Yoav Gershoni IRP Class II 1995-12-08
K954376 MUSTANG Temco, Inc. IOR Class I 1995-12-08
K952680 VARAPULSE-2 Staodyne, Inc. IPF Class II 1995-12-04
K953136 RS-4M Rs Medical IPF Class II 1995-11-30
K955295 SPLASH & GO II Kid'S Wheel-Chairs IOR Class I 1995-11-30
K954370 WHEEL LEMASTER Heliarc Specialists, Inc. IOR Class I 1995-11-29
K952946 VANGATOR II Crow River Industries, Inc. ING Class II 1995-11-29
K953352 PROTEAM CUSHION Iskra.Med KIC Class I 1995-11-29
K953905 IMPERIUM Teledyne Brown Engineering IQA Class II 1995-11-21
K951727 Z-WATCH SYSTEM Prizm Medical, Inc. IPF Class II 1995-11-21
K954328 CLEAN ROOM WHEELCHAIR Forth Research, Inc. IOR Class I 1995-11-17
K932691 PROTECTRODE SYSTEMS CONCENTRIC The Electrode Store, Inc. IKT Class II 1995-11-16
K951770 BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP Biodex Medical Systems, Inc. IKK Class II 1995-11-16
K953621 EVT-3300 U.S. Table, Inc. INQ Class I 1995-11-14
K941144 EXCEL EMG Excel Tech. , Ltd. IKN Class II 1995-11-07
K952442 FREEDOM BATH Grand Traverse Technologies ILJ Class II 1995-11-02
K953887 RE-USABLE CONCENTRIC NEEDLE Chalgren Enterprises, Inc. IKT Class II 1995-10-31
K954568 THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS Reif Wheelchairs and Accessories, Inc. IOR Class I 1995-10-31
K953937 LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM Apt Technology, Inc. IQA Class II 1995-10-31
K953442 RESTORE, THERMACELLS (HOT PACK I) Neal Dunning Assoc., Inc. IMD Class I 1995-10-31
K953886 RE-USABLE MONOPOLAR NEEDLE Chalgren Enterprises, Inc. IKT Class II 1995-10-31
K954670 PRESSORE MONITOR Cleveland Medical Devices, Inc. IKE Class I 1995-10-30
K954162 ERGOSEAT SYSTEM Ergo-Air, Inc. MOC Class II 1995-10-30
K953542 COLDGEL Prism Technologies, Inc. IMD Class I 1995-10-30
K950783 4000+ U.S. Therapy Products, Inc. IPF Class II 1995-10-27
K953614 FORTE Chattanooga Group, Inc. IMG Class II 1995-10-27
K953615 FORTE ES-400 Chattanooga Group, Inc. IPF Class II 1995-10-27
K943007 ITP-HVPC GALVANIC STIMULATOR Innovative Therapy Products, Inc. IPF Class II 1995-10-26
K950656 PED ALERT Orbitec Technologies Corp. IRN Class II 1995-10-25
K951769 CRYOPRESS Grimm Scientific Industries, Inc. IRP Class II 1995-10-16

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