Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 34
- Latest Decision
- 1991-01-18
Clearances · page 37 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K910026 | ATI MEDICAL COMFORT PLUS CPM PAD | Ati Medical, Inc. | BXB | Class I | 1991-01-18 |
| K910151 | ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT | Dyna Flex, Intl. | BXB | Class I | 1991-01-18 |
| K905685 | ZENITH COX FLEXION CHIROPRACTIC TABLE | Williams Manufacturing Co. | INQ | Class I | 1991-01-18 |
| K910149 | ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT | Dyna Flex, Intl. | BXB | Class I | 1991-01-18 |
| K896817 | MODEL T11 FLUIDOTHERAPY UNIT | Henley Intl. | LSB | Class II | 1991-01-18 |
| K903675 | MAGNETIC RESONANCE THERAPY DEVICE | Mrt, Inc. | ILX | Class II | 1991-01-17 |
| K903711 | RHEOLOGIC I | Advanced Rehabilitative Technology, Inc. | IPF | Class II | 1991-01-16 |
| K904998 | THE BODY COOLER SYSTEM | Costa / French | ILO | Class II | 1991-01-14 |
| K910055 | ACME MODEL 8500 WHEELCHAIR SCALE | Acme Medical Scale Co. | INF | Class I | 1991-01-14 |
| K905836 | ULTRA WAVE 101 | Ako USA, Inc. | IRO | Class I | 1991-01-14 |
| K904051 | RICH-MAR MODEL V ULTRASOUND | Rich-Mar Corp. | IMI | Class II | 1991-01-14 |
| K905390 | KUDO (POWERED ROTATION BED) | Kinetic Concepts, Inc. | IKZ | Class II | 1991-01-08 |
| K905756 | TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE | Titan Technology Intl., Inc. | JFB | Class II | 1991-01-08 |
| K905299 | ROMFLEX REHABILITATION EQUIPMENT | Dyna Flex, Intl. | BXB | Class I | 1990-12-31 |
| K905576 | LINGRAPHICA VISUAL LANGUAGE PROSTHESIS | Tolfa Corp. | ILQ | Class II | 1990-12-31 |
| K905271 | PRIDE SPIRIT | Pride Health Care, Inc. | INI | Class II | 1990-12-31 |
| K905671 | BRODA WHEELCHAIR | Broda Ent., Inc. | IOR | Class I | 1990-12-31 |
| K905621 | ELLIPSE 2.3 | Everest & Jennings, Inc. | IOR | Class I | 1990-12-21 |
| K905126 | COMFORT-AIRE | Advanced Air Dynamics, Inc. | IOQ | Class II | 1990-12-19 |
| K905013 | T.C.S. TOTAL CONTACT SEAT | Fundamental Products Co. | KNN | Class I | 1990-12-19 |
| K904819 | SHUR-LOCK ICE WRAP SYSTEM | Conco Medical Co. | IMD | Class I | 1990-12-06 |
| K905293 | SYSTEM 90 AND 95 | Folio Products, Inc. | ITI | Class II | 1990-12-06 |
| K905245 | SPORTS RIDER AND SHOP RIDER | National Health Services, Inc. | INI | Class II | 1990-12-04 |
| K904898 | TORQUE FRAME QTF1000 | Medmetric Corp. | IKK | Class II | 1990-11-28 |
| K905156 | BIO MEDX AIR FLOTATION SYSTEM | Bio Clinic Co. | IOQ | Class II | 1990-11-27 |
| K893924 | MOTO-MED RF-II AND PICO | Holl Meditronics, Inc. | BXB | Class I | 1990-11-27 |
| K904915 | CARESS MASSAGER | Kendex Corp. | ISA | Class I | 1990-11-27 |
| K905113 | ROTO REST; TRAUMA AND INTENSIVE CARE BED | Ethos Medical Products , Ltd. | IKZ | Class II | 1990-11-26 |
| K904796 | MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T | Personal Emergency Response System | ILQ | Class II | 1990-11-26 |
| K904950 | MANUAL AND MOTORIZED FLEXION DISTRACTION TABLES | Leander Research, Mfg & Distr., Inc. | INQ | Class I | 1990-11-26 |
| K904958 | TEMPEST ELECTRIC WHEELCHAIR | Everest & Jennings, Inc. | ITI | Class II | 1990-11-26 |
| K904522 | VARIOUS MODELS OF WHEELCHAIRS | Hadco Marketing Services, Inc. | INI | Class II | 1990-11-26 |
| K905053 | STAGE ZERO AIR FLOTATION BED | Lake Medical Products, Inc. | IOQ | Class II | 1990-11-26 |
| K903617 | MUSCLE MASSAGER | Uri Halfon and Gabriel Hertzberg | ISA | Class I | 1990-11-26 |
| K904818 | XCALIBER | Everest & Jennings, Inc. | ITI | Class II | 1990-11-07 |
| K904913 | HANDI-TRAK WHEELCHAIR SNOW CHAINS | Handi-Trak, Inc. | KNN | Class I | 1990-11-07 |
| K903149 | CHANLLENGE 1010 PATIENT KEY PROGRAM STATION | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1990-11-05 |
| K904862 | HANDI-TRACTION | Handi-Trak, Inc. | ITI | Class II | 1990-11-05 |
| K904817 | MAGNUM | Everest & Jennings, Inc. | ITI | Class II | 1990-11-05 |
| K902255 | OMRON PULSE STIMULATOR MODEL HV-F05 | Omron Electronics, Inc. | IPF | Class II | 1990-10-31 |
| K904113 | OPERATIVE RECORDING CAMERA | Medical Dynamics, Inc. | IKO | Class II | 1990-10-30 |
| K901566 | PROMATRON 3000 | Promatek Medical Systems, Inc. | IKK | Class II | 1990-10-29 |
| K900647 | SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC | Nor-Am Patient Care Products, Inc. | IPF | Class II | 1990-10-22 |
| K902599 | REVISED HIGH VOLTAGE STIMULATOR INTELECT 150 | Chattanooga Group, Inc. | IPF | Class II | 1990-10-22 |
| K903851 | CLUB FOOT CPM MACHINE | Smith & Nephew Richards, Inc. | BXB | Class I | 1990-10-19 |
| K903093 | IONTOPHORESIS DEVICE | Empi | EGJ | Class II | 1990-10-11 |
| K904242 | QI-GONG MACHINE THERAPEUTIC MASSAGER | China Healthways Institute | ISA | Class I | 1990-10-11 |
| K904008 | STAGE IV, AIR-FLUIDIZE BED | Unique Flotation Systems, Inc. | INX | Class II | 1990-10-10 |
| K901902 | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE | Microcurrent Research, Inc. | NUW | Class II | 1990-10-09 |
| K902860 | INTELECT 170 | Chattanooga Group, Inc. | IMG | Class II | 1990-09-27 |
| K902875 | INTELECT 750 MP | Chattanooga Group, Inc. | IMG | Class II | 1990-09-27 |
| K904152 | S.P.F. PREMIER 2 WHEELCHAIR | Everest & Jennings, Inc. | IOR | Class I | 1990-09-19 |
| K903820 | THERA-CANE | Pro Message Co. | LYG | Class I | 1990-09-19 |
| K900189 | CURAPULS 403 DIATHERMY UNIT | Henley Intl. | IMG | Class II | 1990-09-18 |
| K904106 | SPA SHELL | Century Manufacturing Co. | ILJ | Class II | 1990-09-18 |
| K902967 | MICRO-EMED-SYSTEM | Novel Electronics, Inc. | IKE | Class I | 1990-09-17 |
| K903905 | SERIES 9000 LIFT-RECLINE CHAIR | Equi-Tron Mfg., Inc. | INO | Class II | 1990-09-17 |
| K903659 | STAGE III | Unique Flotation Systems, Inc. | IOQ | Class II | 1990-09-17 |
| K903981 | WHEELCHAIRS, TRANSIT/FOLDING/GLIDEABOUT/ACCESS | D.M.A. , Ltd. | IOR | Class I | 1990-09-17 |
| K904069 | BRODA NURSING CARE CHAIR | Broda Ent., Inc. | INN | Class I | 1990-09-17 |
| K903605 | CINTEX | Nanopac, Inc. | ILQ | Class II | 1990-09-14 |
| K902371 | HAELAN 340 MUSCLE STIMULATOR | Paranamics, Inc. | IPF | Class II | 1990-09-12 |
| K902511 | CHALLENGE 7010 POWERED MUSCLE STIMULATOR | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1990-08-31 |
| K902512 | CHALLENGE 8000 POWERED MUSCLE STIMULATOR | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1990-08-31 |
| K902513 | CHALLENGE 6010 POWERED MUSCLE STIMULATOR | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1990-08-31 |
| K902514 | CHALLENGE 5010 POWERED MUSCLE STIMULATOR | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1990-08-31 |
| K901849 | LUMISCOPE EMS 8000 | Lumiscope Co., Inc. | IPF | Class II | 1990-08-24 |
| K903652 | SCAN COM AND SCAN COM P (TENTATIVE) | Med Labs, Inc. | ILQ | Class II | 1990-08-24 |
| K903429 | LIDO LINEA | Loredan Biomedical, Inc. | IKK | Class II | 1990-08-14 |
| K903467 | JACE MODEL 100 KNEE CPM DEVICE | Thera Kinetics, Inc. | BXB | Class I | 1990-08-10 |
| K893980 | LINDQUIST MODEL 370 | R.J. Lindquist Co. | IPF | Class II | 1990-08-02 |
| K892960 | LINDQUIST MODEL SS POWERED MUSCLE STIMULATOR | R.J. Lindquist Co. | IPF | Class II | 1990-08-02 |
| K895000 | NEMECTRON MICROWAVE | Nemectron Medical, Inc. | IOA | Class II | 1990-07-27 |
| K901950 | DITER ULTRASONIC S 3000 | Diter Elektroniikka OY | IMI | Class II | 1990-07-27 |
| K902971 | ZENITH HYLO AND VERTI-LIFT CHIROPRACTIC TABLES | Williams Manufacturing Co. | INQ | Class I | 1990-07-26 |
| K902664 | HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 | Prentke Romich Co. | IQA | Class II | 1990-07-25 |
| K902707 | MODEL 9000 AT ANKLE CPM DEVICE | Sutter Corp. | BXB | Class I | 1990-07-25 |
| K902219 | KRONAMAX HUMAN PERFORMANCE LAB | Physicians Digital Co. | IKK | Class II | 1990-07-25 |
| K901971 | COMFORTRAC TABLE MODEL CT-1000 | Comfortrac Systems | JFB | Class II | 1990-07-25 |
| K903098 | MINI-VIBRATOR | Frank J. Biehl | IRO | Class I | 1990-07-25 |
| K902839 | LIBERTY HOT PACK AND LIBERTY KOLD PACK | Liberty Ent. | IMD | Class I | 1990-07-25 |
| K902951 | SHOWER-A-WAY | Tri-S-Sales and Mfg. | INN | Class I | 1990-07-25 |
| K902895 | INFRASSAGE MASSAGER | Conair Corp. | IRT | Class II | 1990-07-25 |
| K902795 | MODIFIED CHAIRS (DENTAL, MEDICAL, AND PODIATRY) | The Healthcare Group, Inc. | INO | Class II | 1990-07-25 |
| K900450 | BIODEX LIFT SIMULATOR | Biodex Corp. | IKK | Class II | 1990-07-24 |
| K901769 | CHALLENGE 6000 POWERED MUSCLE STIMULATOR | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1990-07-03 |
| K901770 | CHALLENGE 7000 POWERED MUSCLE STIMULATOR | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1990-07-03 |
| K901768 | CHALLENGE 5000 POWERED MUSCLE STIMULATOR | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1990-07-03 |
| K902603 | LIBERTY, FREEDOM & INDEPENDENCE IMMERS HYDRO BATH | Unique Bathing Supplies, Inc. | ILJ | Class II | 1990-06-29 |
| K901779 | RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT | Rich-Mar Corp. | IPF | Class II | 1990-06-26 |
| K895365 | MD-2 IONTOPHORESIS UNIT | R. A. Fischer Co. Corp. | EGJ | Class II | 1990-06-26 |
| K902600 | THE COMPANION NON-ELECTRIC LIFT CHAIR | Innovative Medical Engineering, Inc. | INN | Class I | 1990-06-21 |
| K902268 | PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM. | Seabrook Medical Systems, Inc. | ILO | Class II | 1990-06-21 |
| K902269 | ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY | Seabrook Medical Systems, Inc. | ILO | Class II | 1990-06-21 |
| K902438 | RX ROCKER WHEELCHAIR | The RX Rocker Corp. | IOR | Class I | 1990-06-19 |
| K902439 | RX ROCKER TRIUMPH WHEELCHAIR | The RX Rocker Corp. | IOR | Class I | 1990-06-19 |
| K896874 | DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12 | Dantec Medical, Inc. | IKT | Class II | 1990-06-18 |
| K895460 | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 | Dantec Electronics, Inc. | IKT | Class II | 1990-06-18 |
| K901931 | LEG EEZE | Jereva, Inc. | IRO | Class I | 1990-06-14 |
| K902549 | TITAN GLADIATOR ADJUSTING TABLE | Titan Tables | INQ | Class I | 1990-06-13 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.