Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 38
- Latest Decision
- 1987-02-06
Clearances · page 43 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K865001 | A-BEC FIREBALL 40 | A-Bec Mobility, Inc. | ITI | Class II | 1987-02-06 |
| K865004 | A-BEC 40 POWER WHEELCHAIR | A-Bec Mobility, Inc. | ITI | Class II | 1987-02-06 |
| K865006 | A-BEC 14 | A-Bec Mobility, Inc. | ITI | Class II | 1987-02-06 |
| K864152 | BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE | Lossing Orthopedic, Inc. | ILK | Class II | 1987-02-05 |
| K864569 | PODODIGITAL | Broadwest Corp. | IKE | Class I | 1987-02-04 |
| K864499 | PODOSCOPE | Broadwest Corp. | IKE | Class I | 1987-02-04 |
| K864721 | CRYOTHERM | Grimm Scientific Industries, Inc. | ILJ | Class II | 1987-02-04 |
| K864791 | POIRIER POWERED WHEELCHAIR | Roseburg SA | ITI | Class II | 1987-02-04 |
| K864660 | MODEL M402 EMG MONITOR | Bio-Logic Devices | IKN | Class II | 1987-02-04 |
| K870045 | SKYTRON MODEL 610-2 | Skytron, Div. the Kmw Group, Inc. | INX | Class II | 1987-02-04 |
| K864408 | EMG-1, MOTOR NERVE MONITOR | Algotek, Inc. | IKN | Class II | 1987-01-30 |
| K864641 | VENTEX-IA | Ventech Corp. | IKN | Class II | 1987-01-28 |
| K870043 | GUO GUANG WHEEL CHAIR | China National Medicines & Health Prod. I/E Corp. | IOR | Class I | 1987-01-28 |
| K865072 | ARROW XT POWERED WHEELCHAIR | Ivacare Corp. | ITI | Class II | 1987-01-21 |
| K864581 | APPLIDYN | Grandcor Medical Systems | ISD | Class II | 1987-01-21 |
| K864817 | S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS | S & W Enterprises, Inc. | INQ | Class I | 1987-01-05 |
| K864625 | MYOPAC (TM), MODEL 9600 | Medical Devices, Inc. | IPF | Class II | 1986-12-29 |
| K864653 | MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS | Rich-Mar Corp. | IMJ | Class II | 1986-12-29 |
| K864630 | KC/EMG DIAGNOSTIC ELECTROMYOGRAPH | Chattanooga Group, Inc. | IKN | Class II | 1986-12-29 |
| K864558 | U66 EMS | Suntec Health & Fitness Group, Inc. | IPF | Class II | 1986-12-29 |
| K864284 | MUSCLE MASTER (MEDIUM VOLTAGE STIMULATOR) | Modern Systems Technology, Inc. | IPF | Class II | 1986-12-29 |
| K864918 | HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR | Health Products, Inc. | INO | Class II | 1986-12-24 |
| K864901 | 2000LT WHEELCHAIR | Invacare Corp. | IOR | Class I | 1986-12-24 |
| K864790 | POIRIER MANUAL WHEELCHAIR | Roseburg SA | IOR | Class I | 1986-12-17 |
| K864686 | SCOOTA MOTORIZED VEHICLE | A-Bec Mobility, Inc. | INI | Class II | 1986-12-16 |
| K864324 | ELECTRIFIED TRANSFER TOILET SEAT | Robert E. Roy | ILK | Class II | 1986-12-16 |
| K864366 | COMFORT+LIFT CHAIR | Invacare Corp. | INO | Class II | 1986-12-16 |
| K864232 | ROTATION AIR FLUIDIZED BED/DELTA | Kinetic Concepts, Inc. | IOQ | Class II | 1986-12-16 |
| K864684 | ACTIVE LIGHTWEIGHT WHEELCHAIR | A-Bec Mobility, Inc. | IOR | Class I | 1986-12-16 |
| K864573 | ALT WHEELCHAIR | Alt Design | IOR | Class I | 1986-12-16 |
| K864427 | KNEECPM | Invacare Corp. | BXB | Class I | 1986-12-02 |
| K864010 | EMPI MODEL 712, LOGIX(TM), NMS | Empi | IPF | Class II | 1986-12-02 |
| K862685 | MUSCLE MASTER (BIPOLAR STIMULATOR) | Modern Systems Technology, Inc. | IPF | Class II | 1986-11-25 |
| K864204 | VOCAID, ELECTRONIC VOCAL AID | Texas Instruments, Inc. | ILQ | Class II | 1986-11-14 |
| K864013 | MODEL Q55XT POWERED TREADMILL | Quinton, Inc. | IOL | Class I | 1986-11-14 |
| K864109 | C' AIRECUSH SEAT CUSHION | Medical Industries America, Inc. | KIC | Class I | 1986-11-14 |
| K864108 | PUSH CUSH | Medical Industries America, Inc. | KIC | Class I | 1986-11-14 |
| K863995 | KEYNOTE | Sensory Aids Corp. | ILQ | Class II | 1986-11-13 |
| K863385 | (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE | Cook Urological, Inc. | KNN | Class I | 1986-11-04 |
| K864088 | HITACHI HAND HELD MASSAGER A/C POWERED | Hitachi Sales Corporation of America | ISA | Class I | 1986-11-03 |
| K863884 | PULSESTAR EXERCISE BIKE | Battle Creek Equipment Co. | ISD | Class II | 1986-10-23 |
| K863450 | SULKY SPECIAL | Asc Corp. | LBE | Class I | 1986-10-23 |
| K863654 | RE-HEATER, HOT PACK | K & L Ent. | IME | Class I | 1986-10-23 |
| K863892 | THERACARE LOUNGER | American Theracare | IOR | Class I | 1986-10-23 |
| K862092 | COMFORTRON | M. D. Supply, Inc. | KZM | Class II | 1986-10-15 |
| K850425 | DENTAL ANESTHESIA APPARATUS | Pain Prevention, Inc. | KZM | Class II | 1986-10-09 |
| K863639 | ARTICULAR MOTION DEVICE (AMD4000) | Med Surg Designs, Inc. | BXB | Class I | 1986-09-29 |
| K862932 | THE BIO-TEK UW-II | Bio-Tek Instruments, Inc. | IMJ | Class II | 1986-09-25 |
| K863233 | STC 909ZX POWER BASE | The Stc Companies, Inc. | ITI | Class II | 1986-09-24 |
| K863407 | GRAF CORELLO, POWERED WHEELCHAIR | Graf Products, Inc. | ITI | Class II | 1986-09-23 |
| K863197 | VIBROFLEX | Stoffregen & Co., Inc. | ISA | Class I | 1986-09-19 |
| K863507 | PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS | Physician & Nurses Mfg. Corp. | IMD | Class I | 1986-09-19 |
| K863443 | DUAL FORCEPLATE | Neurocom International, Inc. | KHX | Class I | 1986-09-17 |
| K863383 | FACIAL MASSAGER, BATTERY POWERED | General Physiotherapy, Inc. | ISA | Class I | 1986-09-15 |
| K863313 | GRIP STRENGTH DEVICE (GSD) | Devcom, Inc. | IKK | Class II | 1986-09-09 |
| K863299 | MODIFIED Q50 MEDICAL TREADMILL | Quinton, Inc. | IOL | Class I | 1986-09-09 |
| K863047 | FLEXICAIR | Ssi Medical Services, Inc. | IOQ | Class II | 1986-09-05 |
| K863250 | CHILD'S ROLLS POWERED WHEELCHAIR | Invacare Corp. | ITI | Class II | 1986-08-29 |
| K862957 | MERIVAARA GERIATRIC CHAIR MODEL 455 | Global Medical Prods, Inc. | INN | Class I | 1986-08-21 |
| K863118 | I.D.C. STANDUP WHEELCHAIRS | Intl. Diffusion Consommateur | IPL | Class II | 1986-08-21 |
| K862106 | FORMOSTAR | Lmv, Liske & Methling, GmbH | IRT | Class II | 1986-08-21 |
| K862996 | PORTABLE ISOKINETICS 3004 KNEE UNIT | Kent Design & Manufacturing, Inc. | IKK | Class II | 1986-08-20 |
| K862995 | PORTABLE ISOKINETICS 3003 SHOULDER UNIT | Kent Design & Manufacturing, Inc. | IKK | Class II | 1986-08-20 |
| K862993 | PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT | Kent Design & Manufacturing, Inc. | IKK | Class II | 1986-08-20 |
| K862994 | PORTABLE ISOKINETICS 3002 ISO KANE II | Kent Design & Manufacturing, Inc. | IKK | Class II | 1986-08-20 |
| K862998 | PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT | Kent Design & Manufacturing, Inc. | IKK | Class II | 1986-08-20 |
| K862997 | PORTABLE ISOKINETICS 3005 HIP UNIT | Kent Design & Manufacturing, Inc. | IKK | Class II | 1986-08-20 |
| K862115 | DEKNA BAND KIT | Deknatel, Inc. | ITG | Class I | 1986-08-19 |
| K862887 | UPHOLSTERED BUCKET SEAT | Mednet, Inc. | KNN | Class I | 1986-08-14 |
| K862892 | CASTER CAR | Mednet, Inc. | IOR | Class I | 1986-08-14 |
| K862925 | HEFFINGTON KNEE REST | Lex-Ton Orthopedics | INW | Class I | 1986-08-14 |
| K862885 | CAR SEAT | Mednet, Inc. | INN | Class I | 1986-08-14 |
| K854664 | MEB-5200 | Nihon Kohden America, Inc. | IKT | Class II | 1986-08-14 |
| K862883 | ORTHOPEDIC SEATS | Mednet, Inc. | INN | Class I | 1986-08-14 |
| K862890 | TOILET/SHOWER CHAIR | Mednet, Inc. | IOR | Class I | 1986-08-13 |
| K862895 | TRICYCLES | Mednet, Inc. | IKX | Class I | 1986-08-13 |
| K862894 | SCHOOLTABLE | Mednet, Inc. | INW | Class I | 1986-08-13 |
| K862886 | KOOYCHAIR (PEDIATRIC) | Mednet, Inc. | INM | Class I | 1986-08-13 |
| K862889 | KIRO, WHEELCHAIR FOR CHILDREN | Mednet, Inc. | IOR | Class I | 1986-08-13 |
| K862888 | PERAMBULATOR (STROLLER) | Mednet, Inc. | LBE | Class I | 1986-08-13 |
| K862857 | FRANKLIN CHAIRS/MOVES, #4000 SERIES & #4100 SERIES | Franklin Corp. | INO | Class II | 1986-08-07 |
| K862846 | TEC VARI-TRAC II TRACTION UNIT | Therapeutic Equipment Corp. | ITH | Class II | 1986-08-07 |
| K862236 | MYOLAB II, MODEL ML-200 | Motion Control, Inc. | IKN | Class II | 1986-08-07 |
| K861837 | FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND | Fischer Industries, Inc. | IMG | Class II | 1986-08-07 |
| K862579 | TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 | Tru-Trac | ITH | Class II | 1986-08-06 |
| K862780 | TRU-KINETICS (TM) | Tru-Trac | IKK | Class II | 1986-08-04 |
| K862589 | ULTRATHERM 808 I | Elmed, Inc. | IMJ | Class II | 1986-08-01 |
| K862738 | DANIEL ORTHO BED LIFT AC | Radco | ILK | Class II | 1986-07-29 |
| K862741 | Q50 MEDICAL TREADMILL | Quinton, Inc. | IOL | Class I | 1986-07-29 |
| K862730 | DANNIFLEX 400SL | Danninger Medical Technology, Inc. | BXB | Class I | 1986-07-24 |
| K862376 | NEMECTROSON MODEL 2 | Nemectron Medical, Inc. | IMJ | Class II | 1986-07-23 |
| K862093 | GINGERBREAD MAN (TM) | Southern Pride Manufacturing, Inc. | BXB | Class I | 1986-07-22 |
| K862654 | MODIFIED PENOX LIFT CHAIR | Penox Technologies, Inc. | INO | Class II | 1986-07-18 |
| K862600 | SITZ BATH | W. C. Green, D.D.S. | KTC | Class I | 1986-07-18 |
| K862029 | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT | Elmed, Inc. | IOA | Class II | 1986-07-16 |
| K862487 | MS-139 ELECTRONIC MUSCLE STIMULATOR | Electro Med Supply, Inc. | IPF | Class II | 1986-07-16 |
| K862485 | MS-179 ELECTRONIC MUSCLE STIMULATOR | Electro Med Supply, Inc. | IPF | Class II | 1986-07-16 |
| K862486 | MS-159 ELECTRONIC MUSCLE STIMULATOR | Electro Med Supply, Inc. | IPF | Class II | 1986-07-16 |
| K862405 | RUNAROUND | Everest & Jennings, Inc. | ITI | Class II | 1986-07-15 |
| K862314 | HIP CONTINUOUS PASSIVE MOTION MACHINE | Richards Medical Co., Inc. | BXB | Class I | 1986-07-15 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.