Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 35
- Latest Decision
- 1988-07-18
Clearances · page 41 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K881463 | MULTIMODE(TM) POWER MODULE SYSTEM | Dufco Electronics, Inc. | ITI | Class II | 1988-07-18 |
| K881464 | MULTIMODE(TM) INTERFACE SYS. FOR EVEREST & JENNING | Dufco Electronics, Inc. | ITI | Class II | 1988-07-18 |
| K881804 | MULTI-FLEX TABLE--MODEL 200 | Slenderizers Equipment Mfg., Inc. | JFB | Class II | 1988-07-15 |
| K881705 | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM | Surgi-Med, Inc. | INX | Class II | 1988-07-13 |
| K882669 | APPOLLO BATH | Electric Mobility, LLC | ILK | Class II | 1988-07-08 |
| K882253 | STOUTE'S ASSIST-SEAT WHEELCHAIR COMPONENT | Stoute'S "Assist-Seat" Corp. | KNN | Class I | 1988-06-27 |
| K875052 | TDP, LARK BRAND AND MIT LAMP | I.E.C. Co. | ILY | Class II | 1988-06-23 |
| K881902 | HEALTHTRONIC OMEGA TRAC | Healthtronics Surgical Services, Inc. | JFB | Class II | 1988-06-22 |
| K882139 | 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME | Human Performance Technologies, Inc. | JFC | Class I | 1988-06-22 |
| K882091 | STAIR VEYOR | Pride Health Care, Inc. | ILK | Class II | 1988-05-26 |
| K882090 | HIP SAVER | Pride Health Care, Inc. | INN | Class I | 1988-05-26 |
| K882012 | LIFESTYLE SOF. CARE GEL CHAIR CUSHION | Gaymar Industries, Inc. | KNN | Class I | 1988-05-23 |
| K880871 | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER | John Wagner Associates, Inc. | IMD | Class I | 1988-05-20 |
| K880876 | C-STAT/1000 | Sonne Medical, Inc. | LHC | Class I | 1988-05-20 |
| K881951 | RIDE-LITE 9000 SERIES WHEELCHAIR | Invacare Corp. | IOR | Class I | 1988-05-19 |
| K881766 | REM 250 THREE WHEELED ELECTRIC CART | Royal Enterprises Manufacturing, Inc. | INI | Class II | 1988-05-17 |
| K881634 | SIMPLICITY SERIES 5 | Quartet Technology, Inc. | IQA | Class II | 1988-05-17 |
| K881211 | TRU-TECH 310 ULTRASOUND THERAPY UNIT #310 | Tru-Trac Therapy Products, Inc. | IMI | Class II | 1988-05-11 |
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | Fred Sammons, Inc. | IRQ | Class I | 1988-05-06 |
| K881603 | ULTRA TRACTION | Component Equipment Mfg., Inc. | ITH | Class II | 1988-05-04 |
| K881762 | ROLLS 2000 SERIES WHEELCHAIR | Invacare Corp. | IOR | Class I | 1988-05-04 |
| K875381 | ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER | Ford Laboratories, Inc. | IMI | Class II | 1988-05-03 |
| K880699 | ENDOMED CV405 | Henley Intl. | IPF | Class II | 1988-05-02 |
| K880865 | RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300 | Invacare Corp. | BXB | Class I | 1988-05-02 |
| K873947 | BIO-EMG MODEL 800 | Bio-Research Associates, Inc. | KZM | Class II | 1988-04-27 |
| K874739 | ELECTRIC MOBILITY'S SPARKY | Electric Mobility, LLC | ITI | Class II | 1988-04-22 |
| K873659 | MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO | Universal Gym Equipment, Inc. | IKK | Class II | 1988-04-21 |
| K880948 | RICH-MAR G1000 EMS | Rich-Mar Corp. | IPF | Class II | 1988-04-21 |
| K873658 | ANKLE REFLEX TREATMENT UNIT (ARTU) | Universal Gym Equipment, Inc. | BXB | Class I | 1988-04-21 |
| K881452 | FOLDING WHEELCHAIR | Health Care Innovations, Inc. | IOR | Class I | 1988-04-21 |
| K880631 | 2K-QDA MOTION/GAIT ANALYSIS SYSTEM | Human Performance Technologies, Inc. | LXJ | Class II | 1988-04-21 |
| K881410 | THE ADVENTURER | Westport Mobility Products, Inc. | IOR | Class I | 1988-04-21 |
| K881298 | ASSIST-A-LIFT | Action Engineering, Inc. | INO | Class II | 1988-04-21 |
| K880977 | ADR-2000 AMBULATORY DATA RECORDING SYSTEM | Aaron Laboratories, Inc. | IKN | Class II | 1988-04-13 |
| K880976 | AL-200B MUSCLE ACTIVITY INTEGRATOR | Aaron Laboratories, Inc. | IKN | Class II | 1988-04-13 |
| K880092 | RESUBMITTED FITNESS UPPER BODY ERGOMETER #5100 | Invacare Corp. | BXB | Class I | 1988-04-11 |
| K881024 | ARCHGAUGE(TM) | Archxerciser Corp. | IPF | Class II | 1988-04-08 |
| K880235 | INTELECT MODEL 120 | Chattanooga Group, Inc. | IPF | Class II | 1988-04-08 |
| K880707 | WHEEL-CHAIR W/MOTOR DRIVE | Paul Weiser Co. | ITI | Class II | 1988-03-31 |
| K881082 | GV 11 (TM), MODEL 9700 | Medical Devices, Inc. | IPF | Class II | 1988-03-28 |
| K880573 | MODIFIED NICOLET VIKING SYSTEM | Nicolet Biomedical Instruments | IKN | Class II | 1988-03-22 |
| K881051 | SAFETY PLUS MODEL 501 | Safety Rehab Systems, Inc. | IOR | Class I | 1988-03-21 |
| K880861 | MECHANICAL ADJUSTABLE CHAIR (AC POWERED) | Craftmatic/Contour Organization, Inc. | INO | Class II | 1988-03-17 |
| K880901 | SONICATOR 710 (MODEL ME710) | Mettler Electronics Corp. | IMI | Class II | 1988-03-17 |
| K880398 | POWER TOILET ELEVATOR | Med-West, Inc. | INO | Class II | 1988-03-17 |
| K880230 | SIXALYZER | Lukens Corp. | IKK | Class II | 1988-03-16 |
| K880912 | DYNATRON 2000 | Dynatronics Corp. | IKE | Class I | 1988-03-15 |
| K880800 | GOLDEN POWER LIFT CHAIR | Golden Technologies, Inc. | INO | Class II | 1988-03-14 |
| K880786 | BUSHLINE CARE CHAIR | Bushline Corp. | INO | Class II | 1988-03-14 |
| K880986 | MECHANICAL WALKER | Canhart Industries, Inc. | INM | Class I | 1988-03-14 |
| K875238 | SIEMENS NEUROTON 826 AND 827 | Elmed, Inc. | IPF | Class II | 1988-03-10 |
| K880017 | LIDO(TM) LIFT | Loredan Biomedical, Inc. | IKK | Class II | 1988-02-26 |
| K880686 | TORONTO/MOBILIMB HAND C.P.M. | Toronto Medical Corp. | JFA | Class I | 1988-02-26 |
| K880018 | LIDO(TM) WORKSET | Loredan Biomedical, Inc. | IKK | Class II | 1988-02-26 |
| K880602 | MODIFIED SONICATOR 720, MODEL ME720 | Mettler Electronics Corp. | IMI | Class II | 1988-02-25 |
| K880234 | INTELECT VMS 2, OR INTELECT VMS II | Chattanooga Group, Inc. | IPF | Class II | 1988-02-24 |
| K880486 | DERMGARD SYSTEM 800 AND 900 | Dermgard, Inc. | IOQ | Class II | 1988-02-22 |
| K880424 | SCOOTA BUG (MOTORIZED VEHICLE) | A-Bec Mobility, Inc. | INI | Class II | 1988-02-16 |
| K880336 | MOBILIMB HAND C.P.M. UNIT | Toronto Medical Corp. | JFA | Class I | 1988-02-16 |
| K880425 | STERLING (MOTORIZED VEHICLE) | A-Bec Mobility, Inc. | INI | Class II | 1988-02-16 |
| K880355 | MODEL 938 BATHING SYSTEM | Ferno Ille-Forge | ILJ | Class II | 1988-02-16 |
| K880340 | MODIFIED AIR FLUIDIZED BED, KINAIR | Kinetic Concepts, Inc. | INX | Class II | 1988-02-16 |
| K880423 | TARGA (WHEELCHAIR) | A-Bec Mobility, Inc. | ITI | Class II | 1988-02-16 |
| K874716 | PULSOR, THERAPEUTIC VIBRATOR | Gmg Enterprises, Inc. | ISA | Class I | 1988-02-11 |
| K880032 | MEDEX MACHINE | Medex, Inc. | ISD | Class II | 1988-02-11 |
| K880252 | THERMAL-PAK MODEL SW 1000 | Micro Tek Engineering | LHC | Class I | 1988-02-10 |
| K880280 | BREEZY WHEELCHAIR | Motion Designs, Inc. | IOR | Class I | 1988-02-04 |
| K880271 | RESUBMITTED EXCALIBUR | Quinton, Inc. | ISD | Class II | 1988-02-03 |
| K880222 | ZENITH TRAVELER CHIROPRACTIC TABLE | Williams Manufacturing Co. | INW | Class I | 1988-02-03 |
| K874884 | MEDTRONIC(R) ORTHOFLEX(TM) | Metronic, Inc. | BXB | Class I | 1988-01-28 |
| K875321 | MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE | Kinetic Concepts, Inc. | IOQ | Class II | 1988-01-27 |
| K874736 | RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR | Rich-Mar Corp. | IPF | Class II | 1988-01-22 |
| K871421 | MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT | Futuremed Div. of Future Impex Corp. | IPF | Class II | 1988-01-22 |
| K873819 | MODIFIED STRESS MACHINE | S.J.F., Inc. | ISA | Class I | 1988-01-22 |
| K874843 | VITALON MASSAGER | Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. | ISA | Class I | 1988-01-20 |
| K875103 | BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 | Shield Computers , Ltd. | IKE | Class I | 1988-01-20 |
| K872815 | TRANSJAW(TM) | Vitek, Inc. | BXB | Class I | 1988-01-19 |
| K875235 | ISOKINETIC SYSTEM, TESTING AND EVALUATION | Orthopedic Systems, Inc. | IKK | Class II | 1988-01-19 |
| K873500 | MINI CROSSER BATTERY POWERED WHEELCHAIR | Heisteel DK Aps | INI | Class II | 1988-01-19 |
| K873576 | HUCHEL BODYLINER | Hans-Juergen Huchel | IRT | Class II | 1988-01-19 |
| K872909 | SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION | Elmed, Inc. | IMG | Class II | 1988-01-13 |
| K875034 | SWEDE CHAMP (WHEELCHAIR) | Etac Us, Inc. | IOR | Class I | 1988-01-12 |
| K875035 | SWEDE PETITE (WHEELCHAIR) | Etac Us, Inc. | IOR | Class I | 1988-01-12 |
| K874076 | MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR | Physio Technology, Inc. | IPF | Class II | 1988-01-04 |
| K873125 | SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR | Rehab Medical Specialties, Inc. | IPF | Class II | 1987-12-31 |
| K872606 | TELESONIC BODY STIMULATOR | Telesonic, Inc. | IPF | Class II | 1987-12-22 |
| K874448 | NOVA TRANSFER SYSTEM, MODEL XXX | Nova Technology Corp. | ITI | Class II | 1987-12-17 |
| K873254 | THERMOWRAP, A/K/A/, THERMAL WRAP | Family Sun Tanning | IRT | Class II | 1987-12-11 |
| K874196 | POWER EXERCISE EQUIPMENT | Arc Motion , Ltd. | BXB | Class I | 1987-12-10 |
| K873794 | HOT ROD THERMAL MASSAGE ROLLER | American Progressive Products Corp. | ISA | Class I | 1987-12-10 |
| K873812 | SONICATOR 720 (MODEL ME720) | Mettler Electronics Corp. | IMI | Class II | 1987-12-10 |
| K874060 | CONVERTA-LITTER | Camtec | INN | Class I | 1987-12-10 |
| K874502 | GAIT-AID ORTHOPEDIC INSOLE | Gait-Aid, Inc. | IQI | Class I | 1987-11-30 |
| K873895 | HOT WHEELS | Everest & Jennings, Inc. | ITI | Class II | 1987-11-24 |
| K872974 | DYNATRAC | Med*Ex Diagnostics of Canada, Inc. | IPF | Class II | 1987-11-23 |
| K872970 | THER-A-PULSE | Westec Corp. | IPF | Class II | 1987-11-23 |
| K873612 | IMSI, VITAL CALL | Intl. Management Services, Inc. | IQA | Class II | 1987-11-23 |
| K874246 | IRON HORSE ONE | Iron Horse Productions, Inc. | IOR | Class I | 1987-11-23 |
| K872934 | STAND AID | Stand Aid of Iowa, Inc. | IPL | Class II | 1987-11-23 |
| K872036 | RICH-MAR CONDUCTIVE GEL | Rich-Mar Corp. | IPF | Class II | 1987-11-17 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.