Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 33
- Latest Decision
- 1992-04-07
Clearances · page 35 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K920585 | MAT TABLE, 8100 SERIES MAT PLATFORM | Tri W-G, Inc. | INQ | Class I | 1992-04-07 |
| K920860 | CONTROLLED PASSIVE MOTION MACHINE | U.S. Mfg. & Management, Inc. | BXB | Class I | 1992-04-02 |
| K915144 | DEXTER HAND EVALUATION AND THERAPY SYSTEM | Cedars Medical Center | IKK | Class II | 1992-04-02 |
| K914943 | AQUA MED | Aqua Massage Intl., Inc. | ISA | Class I | 1992-04-02 |
| K921136 | MANUAL TILT CHAIR | Labac Systems, Inc. | IOR | Class I | 1992-04-02 |
| K920463 | ZIPPIE 3 TS/SP WHEELCHAIR/STANDER | Sunrise Medical Quickie Designs, Inc. | IPL | Class II | 1992-04-02 |
| K921027 | MANUAL CHAIR BASE | Labac Systems, Inc. | KNN | Class I | 1992-03-20 |
| K920581 | POLAR PAD (STERILE) | Breg, Inc. | ILO | Class II | 1992-03-20 |
| K912283 | DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE | Chalgren Enterprises, Inc. | IKT | Class II | 1992-03-16 |
| K912282 | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS | Chalgren Enterprises, Inc. | IKT | Class II | 1992-03-16 |
| K903870 | KINESTHETICS MODEL 2000 NMS | Kinesthetics, Inc. | IPF | Class II | 1992-03-13 |
| K920519 | LUMBAR CPM | Rehabilitative Resources, Inc. | BXB | Class I | 1992-03-13 |
| K920654 | SHOPRIDER - TE889 | Pride Health Care, Inc. | INI | Class II | 1992-03-12 |
| K915557 | RICH-MAR MODEL 510 ULTRASOUND | Rich-Mar Corp. | IMI | Class II | 1992-03-10 |
| K920325 | RANGEROLLER (MODIFIED) | Excel Mobility Products, Inc. | ITI | Class II | 1992-03-06 |
| K920270 | CONTINUOUS PASSIVE MOTION MODALITY ACCESSORY | Sports Medical Synergy | BXB | Class I | 1992-03-02 |
| K920180 | QUICKIE P100 | Sunrise Medical Quickie Designs, Inc. | ITI | Class II | 1992-03-02 |
| K914259 | TOUCH TALKER | Prentke Romich Co. | ILQ | Class II | 1992-02-27 |
| K920487 | MINI VIBRATOR | Alimed, Inc. | IRO | Class I | 1992-02-18 |
| K904509 | POWER TRAINER WITH NEUROMUSCULAR STIMULATION | Sinties Scientific, Inc. | IPF | Class II | 1992-02-12 |
| K915092 | TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST | Progressive Medical Technology, Inc. | IRP | Class II | 1992-02-11 |
| K920252 | CURAD KID SIZE INSTANT COLD PACK | Kendall Healthcare Products Co. Div.Of Tyco Health | IMD | Class I | 1992-02-11 |
| K920391 | VOYAGEUR AND LAURENTIAN SERIES WHEELCHAIR | Invacare Corp. | IOR | Class I | 1992-02-11 |
| K920380 | JACE MODEL W550 WRIST CPM DEVICE | Jace Systems, Inc. | BXB | Class I | 1992-02-11 |
| K914234 | SAUNETTE, PORTABLE STEAM CABIN | Sauna Magic, Inc. | IMB | Class II | 1992-02-11 |
| K915637 | TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST. | Progressive Medical Technology, Inc. | IRP | Class II | 1992-02-11 |
| K914774 | MULTIPULSE SEQUENTIAL COMPRESSION UNIT | Talley Group, Ltd. | IRP | Class II | 1992-02-11 |
| K915638 | TALLEY TM200 INTERMTTENT COMPRESSION UNIT | Progressive Medical Technology, Inc. | IRP | Class II | 1992-02-11 |
| K912822 | PERSONAL BODY MASSAGER, MODELS 1605 & 1606 | Raymond Industrial, Ltd. | ISA | Class I | 1992-02-11 |
| K915609 | ULTRA R-11 CRUISER | Brookefield Hunter, Inc. | ITI | Class II | 1992-02-11 |
| K915196 | INCARE HOT/ICE SYSTEM 3 | Hollister, Inc. | ILO | Class II | 1992-02-03 |
| K920112 | CLINITRON C-II | Support Systems Intl. | INX | Class II | 1992-01-24 |
| K913439 | SONIX...THERAPEUTIC SONIC MASSAGE | Mcshirley Products, Inc. | IRO | Class I | 1992-01-22 |
| K915533 | QUICKIE CARBON WHEELCHAIR | Sunrise Medical Quickie Designs, Inc. | IOR | Class I | 1992-01-22 |
| K915659 | THREE WHEEL SCOOTER | Pride Health Care, Inc. | INI | Class II | 1992-01-21 |
| K915784 | INTERSEGMENTAL TRACTION TABLE | Tjn Manufacturing,Inc. | JFB | Class II | 1992-01-14 |
| K915846 | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | IKK | Class II | 1992-01-13 |
| K914737 | ASL MODEL #104 | Adaptive Switch Laboratories, Inc. | ITI | Class II | 1992-01-13 |
| K915671 | B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT | Progressive Medical Technology, Inc. | IOQ | Class II | 1992-01-13 |
| K915108 | FOLDING WHEELCHAIR | Guardian Products Co., Inc. | IOR | Class I | 1992-01-13 |
| K914938 | MICRO COMPUTER CONTROLS, MODEL# MCC-MK-RII-X | Invacare Corp. | ITI | Class II | 1992-01-13 |
| K915262 | BANTEX BRAND WHEELCHAIRS | Bantex Corp. | IOR | Class I | 1992-01-13 |
| K915648 | BIODEX SYSTEM 2 AUTOPROGRAM | Biodex Corp. | IKK | Class II | 1992-01-09 |
| K915152 | RANGEROLLER | Excel Mobility Products, Inc. | ITI | Class II | 1992-01-09 |
| K915629 | CUSHION, WHELCHAR AND FLOTATION | Invacare Corp. | KNN | Class I | 1992-01-09 |
| K913998 | PAM PLUS | Kinetic Concepts, Inc. | IRO | Class I | 1992-01-08 |
| K914860 | SUTTER MODEL 10000 LEG CPM DEVICE | Sutter Corp. | BXB | Class I | 1992-01-08 |
| K914769 | EXTENDO-BAC TABLE | Reinert Technics, Inc. | INW | Class I | 1992-01-08 |
| K914142 | HEMO-PULSE 2000 | Chrono Dynamics, Ltd. | IRP | Class II | 1992-01-03 |
| K914264 | TRANSQ 2 | Iomed, Inc. | EGJ | Class II | 1991-12-20 |
| K915242 | TOUCH N TONE 1 MASSAGER | Conair Corp. | IRO | Class I | 1991-12-20 |
| K915368 | SERENA WHEELCHAIR CUSHIONS | A & C Medical Supply | KNN | Class I | 1991-12-20 |
| K915361 | THE BODY BUGGY | Innova Corp. | LYG | Class I | 1991-12-20 |
| K915241 | SPORTS HEAT WRAP | Conair Corp. | IRT | Class II | 1991-12-20 |
| K914621 | IONTOPHORESIS DEVICE, MODIFICATION | Iomed, Inc. | EGJ | Class II | 1991-12-20 |
| K912854 | TURBO | Kinetic Concepts, Inc. | IOQ | Class II | 1991-12-20 |
| K914776 | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR | Talley Group, Ltd. | JFC | Class I | 1991-12-19 |
| K914780 | TALLEY SD.500 SKIN PRESSURE EVALUATOR | Talley Group, Ltd. | IKE | Class I | 1991-12-19 |
| K914539 | RICH-MAR IFV 1000 | Rich-Mar Corp. | IPF | Class II | 1991-12-18 |
| K904556 | MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB | Boston Scientific Corp | IOL | Class I | 1991-12-18 |
| K911733 | INTELECT, MODEL 245 | Chattanooga Group, Inc. | IMG | Class II | 1991-12-17 |
| K913645 | SPECIALTY CONTROLS INTERFACE | Everest & Jennings, Inc. | ITI | Class II | 1991-12-17 |
| K914738 | ASL MODEL 101 | Adaptive Switch Laboratories, Inc. | ITI | Class II | 1991-12-17 |
| K912140 | STAIRMASTER MODEL 6000 ERGOMETER | Tri-Tech, Inc. | ISD | Class II | 1991-12-17 |
| K914739 | ASL MODEL #102 | Adaptive Switch Laboratories, Inc. | ITI | Class II | 1991-12-16 |
| K914740 | ASL MODEL #103 | Adaptive Switch Laboratories, Inc. | ITI | Class II | 1991-12-16 |
| K913026 | TTU-100THERMAL THERAPY UNIT | Danninger Medical Technology, Inc. | ILO | Class II | 1991-12-13 |
| K903148 | CHALLENGE 3000 NEUROLOGICAL BOOSTER | Maximum Performance Technologies, Mpts, Inc. | IPF | Class II | 1991-12-10 |
| K912342 | DR. LIBERSON'S MICROPULSE NEUROMUSCULAR TRANS STIM | Amer Inst of Electrodiagnosis/Electrotherapy, Inc. | IPF | Class II | 1991-12-09 |
| K914829 | FO92 SEATING MASSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1991-12-09 |
| K914705 | FO41 BODY MASSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1991-12-09 |
| K914830 | A101 LITESSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1991-12-09 |
| K914704 | FO69 FANCY MASSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1991-12-09 |
| K914703 | F383 RECHARGEABLE MINI MASSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1991-12-09 |
| K912642 | EMS300, EMS400, EMS8000 | Skylark Device Co., Ltd. | IPF | Class II | 1991-12-09 |
| K914707 | F055 B.O. FANTASTIC RELAXER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1991-12-09 |
| K914706 | FO51/F151 GOLF MASSAGER | Fairform Mfg., Co., Ltd. | IRO | Class I | 1991-12-09 |
| K911388 | CAVOMAT | Wiest USA, Inc. | IKN | Class II | 1991-12-04 |
| K913973 | INFRARED HEAT LAMPS & MASSAGER MODEL NH-213 | National Health-Care Equipment, Inc. | ILY | Class II | 1991-11-29 |
| K913880 | INFRARED HEAT LAMP MODEL NH-202 | National Health-Care Equipment, Inc. | ILY | Class II | 1991-11-29 |
| K913856 | INFRARED HEAT LAMP MODEL NH-201 | National Health-Care Equipment, Inc. | ILY | Class II | 1991-11-29 |
| K914610 | SWEDE CROSS MANUAL WHEELCHAIR | Etac Us, Inc. | IOR | Class I | 1991-11-29 |
| K914785 | WHEELCHARIOT LIGHTWEIGHT MANUAL WHEELCHAIR | Wheelchariots, Inc. | IOR | Class I | 1991-11-22 |
| K914674 | MICROAIR 3500 | Gsi Development Co. | IOQ | Class II | 1991-11-22 |
| K913654 | SMITH AND DAVIS PRESSURE THERAPY SYSTEM | Smith & Davis Mfg. Co. | INX | Class II | 1991-11-22 |
| K914091 | POWER RECLINER WHEELCHAIR | Everest & Jennings, Inc. | ITI | Class II | 1991-11-19 |
| K912015 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 | Empi | EGJ | Class II | 1991-11-15 |
| K913981 | RICH-MAR MODEL II ULTRASOUND | Rich-Mar Corp. | IMI | Class II | 1991-11-13 |
| K914851 | CLA-1400 SYSTEM | Gaymar Industries, Inc. | IOQ | Class II | 1991-11-13 |
| K914394 | BACK MASTER | Progressive Electrical Therapeutics | BXB | Class I | 1991-11-13 |
| K914553 | ACTION SERIES MANUAL WHEELCHAIRS, VARIOUS MODELS | Invacare Corp. | IOR | Class I | 1991-10-28 |
| K912014 | TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2 | Empi | EGJ | Class II | 1991-10-28 |
| K914125 | FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403 | Ferno | ILJ | Class II | 1991-10-25 |
| K914434 | POLAR PADS | Breg, Inc. | ILO | Class II | 1991-10-24 |
| K912057 | 4000 PT EXERCISE SYSTEM | Tri-Tech, Inc. | ISD | Class II | 1991-10-24 |
| K913759 | DUET BICYCLE/WHEELCHAIR | Robert Hoening Mobility Systems, Inc. | IOR | Class I | 1991-10-24 |
| K912058 | GAUNTLET STAIR CLIMBER | Tri-Tech, Inc. | ISD | Class II | 1991-10-24 |
| K914344 | MULTI-REACH II WAND MASSAGER | Conair Corp. | IRO | Class I | 1991-10-24 |
| K913989 | 510 DL POWERED WHEELCHAIRS | Am Scooters | INI | Class II | 1991-10-24 |
| K913518 | TA620 TREADMILL CONTROLLER | Siemens Burdick, Inc. | IOL | Class I | 1991-10-24 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.