Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 33
- Latest Decision
- 1985-09-24
Clearances · page 45 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K853594 | VESSA FLIVVA | Vessa , Ltd. | ITI | Class II | 1985-09-24 |
| K853045 | ALLY PORTABLE NOT PACK/PAD DISPOSABLE | Actin International, Inc. | IMD | Class I | 1985-09-06 |
| K852036 | AIR PLUS AIR FLUIDIZED THERAPY SYSTEMS | Air Plus, Inc. | INX | Class II | 1985-09-05 |
| K852495 | CAST-TECH CO. COOLING SYSTEM | Cast-Tech Co. | ILO | Class II | 1985-09-05 |
| K852944 | FLEXIMATIC MASSAGER | General Physiotherapy, Inc. | ISA | Class I | 1985-09-05 |
| K851875 | KINNET | Kinetic Concepts, Inc. | INY | Class I | 1985-08-22 |
| K852809 | JAGUAR | Inacare Corp. | ITI | Class II | 1985-08-22 |
| K852811 | RANGER-X | Invacare Corp. | ITI | Class II | 1985-08-22 |
| K852109 | PENOX PERFORMER WHEELCHAIR | Penox Technologies, Inc. | IOR | Class I | 1985-08-22 |
| K852557 | ALL TERRAIN AMIGO | Amigo Sales, Inc. | INI | Class II | 1985-08-22 |
| K852810 | RABBIT | Invacare Corp. | ITI | Class II | 1985-08-22 |
| K852813 | RANGER(II) | Invacare Corp. | ITI | Class II | 1985-08-22 |
| K850852 | INFRARAX DEVICE | Medicon, Inc. | ILY | Class II | 1985-08-21 |
| K852077 | VERSA STIM 380, MUSCLE STIMULATOR | Electro-Med Health Industries, Inc. | IPF | Class II | 1985-08-21 |
| K852610 | HOT PACK | Oriental Medical Supplies, Inc. | IMD | Class I | 1985-08-12 |
| K852604 | MUSCLE MINDER: HEAT WRAP W/ HOT + COLD PACK | Clairol, Inc. | IRT | Class II | 1985-08-12 |
| K852398 | VECTOR BAR SUSPENSION/TRACTION UNIT | Powlan Manufacturing Co. | ILZ | Class I | 1985-08-12 |
| K852399 | TOTAL CPM | Invacare Corp. | BXB | Class I | 1985-08-09 |
| K852380 | SPARROW MOTORIZED SCOOTER | Venturego, Inc. | INI | Class II | 1985-08-07 |
| K852379 | SUNBIRD (POWERED WHEELCHAIR) | Venturego, Inc. | ITI | Class II | 1985-08-07 |
| K851237 | THERMOPHORE ELECTRIC FOMENTATION UNIT | Battle Creek Equipment Co. | IRT | Class II | 1985-07-29 |
| K852065 | PRESTON LOWER LIMB CPM UNIT | Therapeutic Equipment Corp. | BXB | Class I | 1985-07-19 |
| K851946 | REMOTE SPEED CONTROL | Th Charters, Inc. | ISD | Class II | 1985-07-19 |
| K852015 | JYROCHAIR, MODEL SK-H | Medco Products, Co., Inc. | ITI | Class II | 1985-07-19 |
| K852264 | EBI FOOT MASSAGING PUMP | Electro-Biology, Inc. | IRP | Class II | 1985-07-19 |
| K851967 | TORQUE FEEDBACK METER | Th Charters, Inc. | ISD | Class II | 1985-07-19 |
| K851937 | SONOMED 4 | Robert Bosch Corp. | IMI | Class II | 1985-07-17 |
| K851328 | KINETIC AUTO TECHNIC K.A.T. TABLE | Buckman Co., Inc. | JFB | Class II | 1985-07-17 |
| K851331 | EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT) | Empi | BXB | Class I | 1985-07-17 |
| K851631 | TMX-C1/C2 TRADMILL CONTROLLER ACCESS. | Eaton Medical Group | IOL | Class I | 1985-07-15 |
| K851740 | EZZIE SYSTEM | Independent Living, Inc. | IQA | Class II | 1985-07-15 |
| K851814 | WHEELCHAIR CUSHIONS | Dignicare | KIC | Class I | 1985-07-09 |
| K844727 | MODEL 1000 | Verite | IPF | Class II | 1985-07-09 |
| K851550 | MERIVAARA GERIATRIC CHAIR | Daun International, Inc. | INM | Class I | 1985-07-09 |
| K851548 | AHLBERGS KOMBI I & KOMBI II MOBILE TRANSFER CHAIRS | Daun International, Inc. | INM | Class I | 1985-07-09 |
| K851629 | TMX-70 TREADMILL | Eaton Medical Group | IOL | Class I | 1985-07-09 |
| K851553 | MERIUAARA & ERACARE WHEELCHAIRS | Daun International, Inc. | IOR | Class I | 1985-07-09 |
| K851630 | TMX-80 TREADMILL | Eaton Medical Group | IOL | Class I | 1985-07-09 |
| K851381 | POWER DRIVE WHEELCHAIR-VARIOUS | Everest & Jennings, Inc. | ITI | Class II | 1985-07-02 |
| K851397 | SONICATOR 705 MODEL ME 705 | Mettler Electronics Corp. | IMI | Class II | 1985-07-02 |
| K851046 | MYOCARE PLUS DUAL CHANNEL STIMULATOR | 3M Company | IPF | Class II | 1985-07-01 |
| K844126 | SONTEC II | Sontec, Inc. | IPF | Class II | 1985-07-01 |
| K851261 | ALEXIS | Intex Research & Development Center | ITI | Class II | 1985-07-01 |
| K851309 | ABCO PLASTIC UTENSILS | Abco Dealers, Inc. | KTC | Class I | 1985-07-01 |
| K851227 | THE ENDURO | Wheel Ring, Inc. | IOR | Class I | 1985-07-01 |
| K850850 | AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR | Physio Technology, Inc. | IPF | Class II | 1985-07-01 |
| K851257 | CRS ULTRALITE PREMIER | Everest & Jennings, Inc. | IOR | Class I | 1985-06-28 |
| K851256 | MOBIE SCOOTER | Everest & Jennings, Inc. | INI | Class II | 1985-06-28 |
| K851177 | UNIVERSAL POWER FLEX | Biodynamic Technologies, Inc. | BXB | Class I | 1985-06-28 |
| K844779 | HEALTHMASTER- MODEL 8320 MOTORIZED TREADMILL | Roadmaster Corp. | BXB | Class I | 1985-06-28 |
| K850851 | G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S | Physio Technology, Inc. | ISA | Class I | 1985-06-25 |
| K852049 | MEDICAL TOILET SEAT | Pedro Aleman | ILS | Class I | 1985-06-24 |
| K851007 | GRAVITY TRACTION TABLE | William F. Trinkaus | INQ | Class I | 1985-06-21 |
| K851218 | PENOX LIFT CHAIR | Penox Technologies, Inc. | INO | Class II | 1985-06-21 |
| K851037 | ORTHOTRON MUSCLE STIMULATOR MK II DC | Hodgkinson & Corby , Ltd. | IPF | Class II | 1985-06-19 |
| K851027 | SOF. CARE CUSHION & SOF-CARE CUSHION COVER | Gaymar Industries, Inc. | KIC | Class I | 1985-06-18 |
| K851097 | LODE MODEL CORIVAL ERGOMETER | Lode Corp. | ISD | Class II | 1985-06-18 |
| K851065 | GRAVITY KING (DEEMED SE 87/09/18) | Unique Functional Products | ION | Class I | 1985-06-13 |
| K850869 | MFE COUCH ERGOMETER | Ketronic, Inc. | ISD | Class II | 1985-06-12 |
| K850877 | MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR | Ketronic, Inc. | ILK | Class II | 1985-06-12 |
| K850873 | HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL | Ketronic, Inc. | INO | Class II | 1985-06-12 |
| K850871 | TREDBAND TYPE I, IT, II & III - TREADMILLS | Ketronic, Inc. | BXB | Class I | 1985-06-05 |
| K850566 | MARUKYR-BAN / HOT OR HEAT PACK | Oriental Medical Supplies, Inc. | IMD | Class I | 1985-05-29 |
| K850698 | MEDIUM FREQU. ELEC. MUSCLE STIMULATOR | Chattanooga Group, Inc. | IPF | Class II | 1985-05-17 |
| K844118 | THERAPEUTIC LIMB MANIPULATOR | Donald E. Redding | BXB | Class I | 1985-05-17 |
| K850573 | CURAMED 402 | Fluidotherapy Corp. | IMJ | Class II | 1985-05-17 |
| K850876 | LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR | Ketronic, Inc. | ITI | Class II | 1985-05-16 |
| K850508 | LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES | Kal Life Systems | EGJ | Class II | 1985-05-15 |
| K850640 | SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT | Fluidotherapy Corp. | IMI | Class II | 1985-05-14 |
| K850771 | OSTER MASSAGE WAND STICK MASSAGER 295-07 | Daito Electric Machine Industries Company, Ltd. | ISA | Class I | 1985-05-14 |
| K844387 | ESCOTEK-EST 221 VACUUM UNIT | Nor-Am Patient Care Products, Inc. | IPF | Class II | 1985-05-07 |
| K850453 | SINUS AC-POWERED MUSCLE STIMULATOR | Zimmer Elektromedizin GmbH | IPF | Class II | 1985-05-07 |
| K844390 | ESCOTEK-EST 204 MULTI STIM | Nor-Am Patient Care Products, Inc. | IPF | Class II | 1985-05-07 |
| K844389 | ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI | Nor-Am Patient Care Products, Inc. | IPF | Class II | 1985-05-07 |
| K844388 | ESCOTEK EST 220 INTERFERENCE THERAPY UNIT | Nor-Am Patient Care Products, Inc. | IPF | Class II | 1985-05-07 |
| K850536 | QUICKIE WHEELCHAIRS | Motion Designs, Inc. | IOR | Class I | 1985-05-02 |
| K850332 | KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE | Richards Medical Co., Inc. | BXB | Class I | 1985-05-01 |
| K844385 | ESCOTEK EST TRAC 401 | Nor-Am Patient Care Products, Inc. | ITH | Class II | 1985-05-01 |
| K850377 | HI-LO TILT TABLE 625 | Tri W-G, Inc. | INQ | Class I | 1985-05-01 |
| K844386 | ESCOTEK-EST 301A ULTRA-SONIC UNIT | Nor-Am Patient Care Products, Inc. | IMI | Class II | 1985-05-01 |
| K850178 | DALTON FOLDING WHEELCHAIRS | Dalton Instrument Corp. | IOR | Class I | 1985-04-25 |
| K850274 | SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT | Sutter Biomedical, Inc. | BXB | Class I | 1985-04-25 |
| K850313 | TELEVISION CONTROL OPTION 1219 | Rehab Technology, Inc. | IQA | Class II | 1985-04-25 |
| K850314 | TELEVISION CONTROL OPTION 1220 | Rehab Technology, Inc. | IQA | Class II | 1985-04-25 |
| K850637 | EXOTHERMIC HEATING PAD | Travenol Laboratories, S.A. | IMD | Class I | 1985-04-25 |
| K850030 | CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE | Arc Motion , Ltd. | BXB | Class I | 1985-04-25 |
| K850465 | CERVICAL COLLARS & HEAD HALTERS | Abco Dealers, Inc. | IQK | Class I | 1985-04-25 |
| K850013 | SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR | Mettler Electronics Corp. | IPF | Class II | 1985-04-08 |
| K850044 | TREADMILL E-17 | Del Mar Avionics | IOL | Class I | 1985-04-04 |
| K850064 | WHEELCHAIR, MECHANICAL | Comaco, Inc. | IOR | Class I | 1985-04-04 |
| K844995 | SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE | Cropper Medical, Inc. | BXB | Class I | 1985-04-01 |
| K844847 | MOBILCHAIR 360 ELECTRIC-POWERED CHAIR | Davis-Smith Corp. | ITI | Class II | 1985-03-13 |
| K844416 | THERMOPULS E | Nemectron Medical, Inc. | IMJ | Class II | 1985-03-12 |
| K844890 | TELL ME TAGS - NONPOWERED COMMUNICATION SYS | Mina Manufacturers, Inc. | ILP | Class I | 1985-03-08 |
| K844489 | ELECTRONIC MUSCLE STIMULATOR | Beverly Hills Exercise Equipment | IPF | Class II | 1985-03-05 |
| K844712 | MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO | Tri W-G, Inc. | INQ | Class I | 1985-03-05 |
| K844799 | ARTISAN FOLDING WHEELCHAIRS | Artisan Wheel Chair Manufacturers | IOR | Class I | 1985-03-05 |
| K844617 | EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE | Excel Tech. , Ltd. | IPF | Class II | 1985-03-05 |
| K850047 | SANYO ELECTRONIC MUSCLE STIMULATORS | General Physiotherapy, Inc. | IPF | Class II | 1985-03-05 |
| K844711 | MODELS 134, 135 & 136 TRANSFER CART/TABLE | Tri W-G, Inc. | INK | Class II | 1985-03-05 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.