meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
38
Latest Decision
1991-10-24

Clearances · page 36 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K912056 GRAVITRON UPPER BODY SYSTEM EXERCISER Tri-Tech, Inc. ISD Class II 1991-10-24
K913444 GLOBALCARE EMS Globalcare Intl., Inc. IPF Class II 1991-10-21
K913729 POLAR PUMP, MODEL 500 Breg, Inc. ILO Class II 1991-10-18
K914182 GOLDEN THERMAL(R) Seabrook Medical Systems, Inc. ILO Class II 1991-10-18
K904360 CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR Maximum Performance Technologies, Mpts, Inc. IPF Class II 1991-10-15
K912383 VIBRATOUCH II CORDLESS WAND MASSAGER Conair Corp. ISA Class I 1991-10-07
K913901 FREEDOM WHEELS AZ 100 Arizona Freedom Wheels, Inc. ITI Class II 1991-10-07
K913021 BIODEX,MODEL B-2000 Biodex Corp. IKK Class II 1991-10-03
K913020 BIODEX SYSTEM 2,MODEL S2-S Biodex Corp. IKK Class II 1991-10-03
K912715 INSTANT WARM GEL PACK Prism Technologies, Inc. IMD Class I 1991-10-02
K911758 AMISH COUNTRY SPA Fox Pool Corp. ILJ Class II 1991-10-02
K911574 PNEU-WAVE Pneu-Mobility, Inc. JFB Class II 1991-10-02
K914103 LIFELINE(R) PERSONAL RESPONSE SYSTEM Lifeline Systems, Inc. ILQ Class II 1991-09-27
K913510 MECHANICAL SHAPE SENSOR Pin Dot Products, Inc. JFC Class I 1991-09-23
K912202 RICH-MAR MODEL 25 ULTRASOUND Rich-Mar Corp. IMI Class II 1991-09-17
K912634 CORDLESS ELECTRIC MASSAGER EV315 Matsushita Electric Co. ISA Class I 1991-09-12
K912722 HYPER-K HEAT SYSTEM Baxter Healthcare Corp ILO Class II 1991-09-11
K901732 EMG ACCESSORY FOR POSTUROGRAPHY Neurocom International, Inc. IKN Class II 1991-09-10
K912512 TAICHI STICK MASSAGER Focus International, Inc. LYG Class I 1991-09-06
K912855 HAZEL Kinetic Concepts, Inc. IOQ Class II 1991-09-06
K912659 SOUND RELIEF Windmere Corp. IRO Class I 1991-09-06
K911551 SHOWER MINI RD-7 SANITARY WASHER Aiex USA , Ltd. ILJ Class II 1991-09-06
K913549 PIN DOT MOUNTING BRACKETS Pin Dot Products, Inc. KNN Class I 1991-09-05
K913548 PIN DOT ALUMINUM PAN Pin Dot Products, Inc. KNN Class I 1991-09-05
K913545 PIN DOT FLIP-DOWN ABDUCTOR Pin Dot Products, Inc. KNN Class I 1991-09-05
K913546 IMPALA CASTERS Pin Dot Products, Inc. KNN Class I 1991-09-05
K913511 IMPALA AXLES Pin Dot Products, Inc. KNN Class I 1991-09-05
K913550 PIN DOT TRUNION MOUNTS Pin Dot Products, Inc. KNN Class I 1991-09-05
K913507 ARMREST Pin Dot Products, Inc. KNN Class I 1991-09-05
K913553 PIN DOT GROWTH/DIAL LINKS Pin Dot Products, Inc. KNN Class I 1991-09-05
K913509 IMPALA WHEELS Pin Dot Products, Inc. KNN Class I 1991-09-05
K910801 HIGH VOLTAGE PULSED GALVANIC STIMULATION APPLICATI Psychoenergetic Systems, Inc. IPF Class II 1991-09-04
K913552 PIN DOT FOOTREST PRODUCTS Pin Dot Products, Inc. KNN Class I 1991-08-29
K913512 IMPALA Pin Dot Products, Inc. IOR Class I 1991-08-29
K913544 DUKKI Pin Dot Products, Inc. INM Class I 1991-08-29
K912179 THE SPRITZ BATH The Spritz Co. KTC Class I 1991-08-28
K912320 BIOPHYSIOMETER POSITIONING CHAIR Bi-Dynamics, Inc. INO Class II 1991-08-22
K913272 EMS/400 Altoona Medical Supply IPF Class II 1991-08-22
K912661 MATRX, PYRAMID TRIANGLE BANDAGE Matrix Medica, Inc. ILI Class I 1991-08-21
K905107 UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 Universal Technology Systems, Inc. IPF Class II 1991-08-19
K912537 JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION Thera Kinetics, Inc. BXB Class I 1991-08-16
K913227 JACE MODEL T300 TOE CPM DEVICE Thera Kinetics, Inc. BXB Class I 1991-08-16
K911195 DUNLAP HEAT PAD Home Healthcare Products, Inc. IRT Class II 1991-08-12
K912479 MOTOR MASSAGE PILLOW Supreme Import , Ltd. IRO Class I 1991-08-09
K912086 FMA TRANSLATOR Normandie Group, Inc. BXB Class I 1991-08-07
K912227 MONARK ERGOMETERS Quinton, Inc. ISD Class II 1991-08-07
K912004 SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS Shepherd Medical Products, Inc. IRP Class II 1991-07-25
K911943 CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM Burke, Inc. ILO Class II 1991-07-19
K903660 DERMALIGHT PSORACOMB Solitec GmbH IOB Class II 1991-07-17
K911119 SOPUR GMBH WHEELCHAIRS Sopur GmbH IOR Class I 1991-07-16
K912071 SPACE(TM) 7500 F.M. Wiest USA, Inc. IKN Class II 1991-07-09
K911666 MEDX MACHINE Medx Corp. IKK Class II 1991-07-03
K911805 KIN-COM ASYMMETRICAL BACK SYSTEM Chattanooga Group, Inc. IKK Class II 1991-07-03
K904963 EXTEND TRACK UNIT Anthony Chiropractic Clinic, Inc. BXB Class I 1991-06-28
K904246 SYSTEM 70 AND 100 Folio Products, Inc. ITI Class II 1991-06-10
K905292 SYSTEM 50 Folio Products, Inc. ITI Class II 1991-06-10
K912175 ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE Isotechnologies, Inc. INK Class II 1991-06-07
K911246 THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 The Medical Group, Inc. INX Class II 1991-06-06
K911416 ELITE SYSTEM Gfb Intl. Trading, Inc. LXJ Class II 1991-06-06
K910867 T600 TREADMILL Siemens Burdick, Inc. IOL Class I 1991-05-31
K911986 RAMP RAT Vehicle Dynamics ITI Class II 1991-05-31
K910091 ULTRALITE PANELITE Ultralite IOB Class II 1991-05-30
K911843 ZERO-G(TM) GEL/FOAM MATTRESS TOPPER Steridyne Corp. KIC Class I 1991-05-30
K911751 MEDTRACK TREADMILL Quinton, Inc. IOL Class I 1991-05-29
K911151 POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM Tarsys Engineering, Inc. ITI Class II 1991-05-29
K910708 RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE Rich-Mar Corp. IMI Class II 1991-05-21
K904650 WHEELCHAIR CONVERSION KIT Hadco Marketing Services, Inc. ITI Class II 1991-05-21
K910851 TASSI MK3 (TURNAIR) Therapy Air Support Systems, Inc. IOQ Class II 1991-05-15
K904332 MSTIM-2000 EMS Oms Medical Supplies, Inc. IPF Class II 1991-05-01
K911101 TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM Zofcom, Inc. IQA Class II 1991-04-25
K911608 GRANSTAND Prime Engineering IPL Class II 1991-04-23
K910749 FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIR Fortress Litestyle ITI Class II 1991-04-22
K910751 FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTER Fortress Litestyle INI Class II 1991-04-22
K910753 FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR Fortress Litestyle ITI Class II 1991-04-22
K905647 JENSEN III CHIROPRACTIC J-TABLE Freedman, Wolk and Co. INQ Class I 1991-04-19
K911057 DERMATEK 4000 Anacom General Corp. INX Class II 1991-04-05
K910519 GOOD VIBRATIONS TUBE MASSAGER Dual Voltage, Inc. ISA Class I 1991-04-01
K911152 QUAD-LINK RETRACTABLE MOUNT Tarsys Engineering, Inc. ITI Class II 1991-03-26
K905599 JETTA JR. HYDRO MASSAGE Jetta Products, Inc. ILJ Class II 1991-03-26
K910974 MCCONNELL SHOULDER BRACE Mcconnell Orthopedic IQI Class I 1991-03-21
K910747 FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR Fortress Litestyle IOR Class I 1991-03-21
K905256 NEXT WAVE(R) PHYSIOACCOUSTIC(TM) CHAIR Next Wave, Inc. IOR Class I 1991-03-12
K910819 COMPANION SPEECH AID, MODEL 160 Companion Products Intl. ILQ Class II 1991-03-07
K910796 COMPANION SPEECH AID, MODEL 432 Companion Products Intl. ILQ Class II 1991-03-07
K910750 FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR Fortress Litestyle IOR Class I 1991-03-05
K910746 FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR Fortress Litestyle IOR Class I 1991-03-05
K910748 FORTRESS EDGE MANUAL RIGID WHEELCHAIR Fortress Litestyle IOR Class I 1991-03-05
K910752 FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIR Fortress Litestyle IOR Class I 1991-03-05
K905474 THE EYEGAZE SYSTEM Lc Technologies, Inc. ILQ Class II 1991-02-28
K910607 PACIFIC MARQUIS SPA Marquis International , Ltd. ILJ Class II 1991-02-21
K905718 ROMFLEX Paraflex Corp. BXB Class I 1991-02-19
K903321 SANDBOX I, SANDBOX II, SANDBOX JR. Sandbox Ent. IRT Class II 1991-02-19
K905525 CYBEX 6000 Cybex IKK Class II 1991-02-14
K910265 TRAVELER, MOTORIZED THREE-WHEELED VEHICLE Pillar Technology, Inc. INI Class II 1991-02-14
K910061 K-MODULE II HEAT THERAPY SYSTEM Baxter Healthcare Corp ILO Class II 1991-02-13
K902803 A PHYSIOTHERAPY APPARATUS Grace River Ent., Inc. ILY Class II 1991-02-06
K904735 DANNIFLEX MODEL 500TM CPM Buckman Co., Inc. BXB Class I 1991-01-30
K904823 FLEXERCYCLE Medmetric Corp. ISD Class II 1991-01-30
K910150 ROMFLEX REHAB EQUIP EXTREMITIES UNIT Dyna Flex, Intl. BXB Class I 1991-01-23
K905207 MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS Micro Surgical Instruments Corp. IME Class I 1991-01-22

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