Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 36
- Latest Decision
- 1993-02-12
Clearances · page 34 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K923637 | ARJO-CENTURY ARM AND LEG TANK SYSTEM | Arjo-Century, Inc. | ILJ | Class II | 1993-02-12 |
| K925043 | ELBOW CPM ORTHOSIS | Electrobionics Corp. | BXB | Class I | 1993-02-12 |
| K923753 | ABLE GENERATION THERAPY TILT BENCH | The Able Generation, Inc. | INN | Class I | 1993-01-29 |
| K923750 | ABLE GENERATION BOOSTER CHAIR | The Able Generation, Inc. | INN | Class I | 1993-01-29 |
| K923752 | ABLE GENERATION PLAY CHAIR | The Able Generation, Inc. | INN | Class I | 1993-01-29 |
| K923751 | ABLE GENERATION DESK | The Able Generation, Inc. | INW | Class I | 1993-01-29 |
| K920389 | RS-2 NEUROMUSCULAR STIMULATOR | Rs Medical | IPF | Class II | 1993-01-28 |
| K920388 | RS-1 NEUROMUSCULAR STIMULATOR | Rs Medical | IPF | Class II | 1993-01-28 |
| K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | Myo-Tronics, Inc. | KZM | Class II | 1993-01-07 |
| K922900 | INFRARED LAMP | Harrier, Inc. | ILY | Class II | 1992-11-24 |
| K923796 | BOBCAT | Mobility Mfg. Co. | INI | Class II | 1992-11-17 |
| K923103 | JT-1 POWERED TRACTION UNIT | Chirotronics, Inc. | ITH | Class II | 1992-11-09 |
| K923617 | FULL MOVEMENT THERAPY SYSTEMS | Arjo-Century, Inc. | ILJ | Class II | 1992-11-09 |
| K923973 | SPACE BASE ELECTRIC TILT TABLE | Midland Mfg. Co. | INQ | Class I | 1992-11-09 |
| K923998 | MIDLAND TILT TABLE | Midland Mfg. Co. | INQ | Class I | 1992-11-09 |
| K923494 | PARAMED LATERAL FLEXION MACHINE | Paramed Div | BXB | Class I | 1992-11-09 |
| K924002 | MIDLAND THREE SECTION P.T. TABLE W/ DRAINAGE | Midland Mfg. Co. | INQ | Class I | 1992-11-09 |
| K923797 | MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED | Rich-Mar Corp. | IMG | Class II | 1992-11-06 |
| K923914 | IF-II (TM), MODEL 7200 | Medical Devices, Inc. | IPF | Class II | 1992-11-06 |
| K923819 | EEC-1 PACKAGE | Med Labs, Inc. | ILQ | Class II | 1992-11-06 |
| K912328 | ELECTRONIC MUSCLE STIMULATORS, EXCEL II, MODIFIED | Advanced Rehabilitative Technology, Inc. | IPF | Class II | 1992-11-06 |
| K924019 | DELUXE ELECTRIC COMBINATION TILT TABLE | Midland Mfg. Co. | INQ | Class I | 1992-11-06 |
| K915326 | PORTABLE LIMB LOAD MONITOR (BMLLM-100) | Bar Med Pty , Ltd. | IKE | Class I | 1992-10-20 |
| K920526 | STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500 | Stryker Medical | IOG | Class I | 1992-09-21 |
| K922473 | TURN EZ BED DEVICE | Med-Ez, Inc. | IKZ | Class II | 1992-09-09 |
| K923186 | NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC | Roho, Inc. | KNN | Class I | 1992-09-09 |
| K922719 | WILLIAMS ADVANTAGE ELEVATION TABLE | Williams Manufacturing Co. | INQ | Class I | 1992-08-07 |
| K923291 | NAICO WHEEL CHAIRS | Naico Corp. | IOR | Class I | 1992-08-06 |
| K923159 | ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS | Arjo-Century, Inc. | ILJ | Class II | 1992-08-06 |
| K920105 | SCALAMOBIL | Alber Technologies, Inc. | ING | Class II | 1992-08-06 |
| K921348 | OIC MODEL J4 TMJ CPM | Lm Product Design, Inc. | BXB | Class I | 1992-08-05 |
| K922967 | FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER | Fortress Scientific , Ltd. | INI | Class II | 1992-08-03 |
| K923216 | DANNINFLEX CPM 800 | Buckman Co., Inc. | BXB | Class I | 1992-08-03 |
| K915416 | FYMCO FLYER | Motion Dynamics | INI | Class II | 1992-08-03 |
| K923217 | DANNIFLEX CPM 2000 | Buckman Co., Inc. | BXB | Class I | 1992-08-03 |
| K922966 | FORTRESS 1704FS FOUR WHEEL SCOOTER | Fortress Scientific , Ltd. | INI | Class II | 1992-08-03 |
| K921668 | STAODYN TUWAVE | Staodyne, Inc. | IPF | Class II | 1992-08-03 |
| K922973 | RESTCUE CC | Support Systems Intl. | IOQ | Class II | 1992-07-30 |
| K922493 | AMERICAN MEDICAL MFG. LUMBAR CPM | American Medical Corp. | BXB | Class I | 1992-07-27 |
| K922535 | THE TERMINATOR | Top End Wheelchair Sports, Inc. | IOR | Class I | 1992-07-24 |
| K923350 | CLOSED CHAIN ATTACHMENT, MODEL #820-520 | Biodan Medical Systems, Ltd. | IKK | Class II | 1992-07-23 |
| K923325 | MODEL 600 MEDICAL TREATMENT TABLE | Tri W-G, Inc. | INQ | Class I | 1992-07-21 |
| K923095 | KAYE MODEL KIAO PELVIC/THIGH STABILIZER | Kaye Products, Inc. | INN | Class I | 1992-07-21 |
| K921540 | COOLING/HEATING THERAPY DEVICE | Tempacure Home Care | ILO | Class II | 1992-07-21 |
| K920532 | ACU-TRAIN V (5) | Sterne Medical Equipment Div. Ontario , Ltd. | IPF | Class II | 1992-07-17 |
| K923193 | SUNRUNNER TE-777 | Pride Health Care, Inc. | INI | Class II | 1992-07-17 |
| K915321 | BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR | Bt Medical Co., Inc. | IPF | Class II | 1992-07-17 |
| K922980 | 745-M (MAGNUM) | Tri W-G, Inc. | JFB | Class II | 1992-07-13 |
| K922366 | SPINE LINE | Dambrecine, Inc. | LYG | Class I | 1992-07-13 |
| K922772 | TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR | Biodan Medical Systems, Ltd. | IKK | Class II | 1992-07-13 |
| K922624 | ULTRAGATER WHEELCHAIR LIFT | Crow River Industries, Inc. | ING | Class II | 1992-07-13 |
| K921711 | FLEXION DISTRATION SUPPORT | Altoona Medical Supply | ILZ | Class I | 1992-07-13 |
| K921446 | HOT OR COLD PACK (THERMIPAQ) | Thermionics Corp. | IME | Class I | 1992-07-13 |
| K922965 | TUMBLE FORMS TRISTANDER | Tumble Forms | INW | Class I | 1992-07-13 |
| K922160 | AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS | Aquamotion, Inc. | ILJ | Class II | 1992-06-19 |
| K922304 | ROADRUNNER ELECTRIC SCOOTER-3 WHEELED | Mobility Mfg. Co. | INI | Class II | 1992-06-19 |
| K922602 | CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 | Biodan Medical Systems, Ltd. | ISD | Class II | 1992-06-19 |
| K922305 | COYOTE ELECTRIC SCOOTER-3WHEELED | Mobility Mfg. Co. | INI | Class II | 1992-06-19 |
| K922606 | MULTI JOINT WEIGHT SYSTEM MODEL #940-100 | Biodan Medical Systems, Ltd. | ISD | Class II | 1992-06-19 |
| K922603 | TOTAL WORK INTEGRATOR, MODEL #940-110 | Biodan Medical Systems, Ltd. | ISD | Class II | 1992-06-19 |
| K920686 | ORTHO-PLEX-REHABILITATION SYSTEM | Plexus Intl., Inc. | BXB | Class I | 1992-06-11 |
| K922338 | X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER | Am Scooters | INI | Class II | 1992-06-11 |
| K922185 | JACE KNEE EXTENSION SYSTEM -- MODIFICATION | Jace Systems, Inc. | BXB | Class I | 1992-06-11 |
| K912462 | Q-MS NEUROMUSCULAR STIMULATOR | Quantitative Medicine, Inc. | IPF | Class II | 1992-06-04 |
| K921323 | CERVICAL PASSIVE MOTION | Rehabilitative Resources, Inc. | BXB | Class I | 1992-06-03 |
| K921633 | ORS-2000 SERIES | Mnlase, Inc. | LHC | Class I | 1992-06-02 |
| K914231 | ELPHA 2000 | Biometer Intl. A/S | IPF | Class II | 1992-05-28 |
| K922140 | ORTHODERM CONVERTIBLE II | Bio Clinic Co. | IOQ | Class II | 1992-05-27 |
| K921917 | DOLOMITE ROLLATOR | Seamark Technologies | INM | Class I | 1992-05-26 |
| K922061 | CHAIR, ADJUSTABLE, MECHANICAL | Kaye Products, Inc. | INN | Class I | 1992-05-26 |
| K922107 | TAYLOR MADE MOBILE STANDER | Nelson A. Taylor Co., Inc. | IPL | Class II | 1992-05-26 |
| K922045 | SHOWER CHAIRS | Medical Device Inspection Co., Inc. | INM | Class I | 1992-05-26 |
| K922092 | SINGLE CHAIR INTEGRAL BACK ATTACHMENT | Biodan Medical Systems, Ltd. | IKK | Class II | 1992-05-26 |
| K921070 | FORTRESS 760-N 4 WHEEL POWER WHEELCHAIR | Fortress Scientific , Ltd. | ITI | Class II | 1992-05-26 |
| K921340 | FORCE MEASURING PLATFORM | Sra Intl., Inc. | KHX | Class I | 1992-05-26 |
| K921894 | RIFTON MOBILE PRONE STANDERS | Rifton Equipment For the Handicapped | IPL | Class II | 1992-05-26 |
| K921847 | ACTION FX MANUAL WHEELCHAIR | Invacare Corp. | IOR | Class I | 1992-05-22 |
| K920833 | RICH-MAR HV 1000 MUSCLE STIMULATOR | Rich-Mar Corp. | IPF | Class II | 1992-05-22 |
| K920436 | MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR | Medtronic Vascular | IPF | Class II | 1992-05-20 |
| K920091 | IOWA ORAL PERFORMANCE ISNTRUMENT | Breakthrough, Inc. | IKE | Class I | 1992-05-20 |
| K921369 | BIOMEDICAL HORIZONS MODEL 1001 | Biomedical Horizons, Inc. | KNN | Class I | 1992-05-11 |
| K915230 | H WAVE MUSCLE STIMULATOR | Electronic Waveform Laboratory, Inc. | IPF | Class II | 1992-05-08 |
| K921351 | JACE MODEL PM-410 HAND CPM DEVICE | Jace Systems, Inc. | JFA | Class I | 1992-05-04 |
| K921648 | BRUNO ELECTRA-RIDE STAIR-WAY ELEVATOR SYSTEM | Bruno Independent Living Aids, Inc. | ILK | Class II | 1992-05-04 |
| K921647 | REGAL MOTORIZIED 3 WHEELED VEHICLE | Bruno Independent Living Aids, Inc. | INI | Class II | 1992-05-04 |
| K921752 | AMBULATOR | The Anthros Medical Group | INM | Class I | 1992-05-04 |
| K921467 | DRAKE & DRAKE/200 DL | Am Scooters | INI | Class II | 1992-04-29 |
| K920179 | ZIPPIE P500 | Sunrise Medical Quickie Designs, Inc. | IOR | Class I | 1992-04-29 |
| K921817 | RIFTON MOR219 19 & RIFTON MOR225 25 | Rifton Equipment For the Handicapped | INM | Class I | 1992-04-29 |
| K915729 | AUQASOOTHE/AQUA MED | Aquasoothe | ISA | Class I | 1992-04-29 |
| K921069 | FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER | Fortress Scientific , Ltd. | INI | Class II | 1992-04-29 |
| K921768 | HAZEL II | Kinetic Concepts, Inc. | IOQ | Class II | 1992-04-29 |
| K914904 | THERAPEUTIC STIMULATOR 2100 (TS-2100) | Myo/Kinetic Systems, Inc. | IPF | Class II | 1992-04-28 |
| K914999 | BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) | Bt Medical Co., Inc. | IPF | Class II | 1992-04-23 |
| K921528 | HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM | Hill-Rom, Inc. | IQA | Class II | 1992-04-20 |
| K921272 | ACTIVITY CHAIR | Rifton Equipment For the Handicapped | INN | Class I | 1992-04-07 |
| K915278 | CDG GAIT ANALYSES SYSTEM | Wrm Computers | JFC | Class I | 1992-04-07 |
| K921084 | THE EXCELSIOR | Rehab Technology, Inc. | IPL | Class II | 1992-04-07 |
| K915897 | FPL | Wrm Computers | IKE | Class I | 1992-04-07 |
| K920382 | FLEXICAIR LOW AIRLOSS THERAPY UNIT | Support Systems Intl. | IOQ | Class II | 1992-04-07 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.