Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 29
- Latest Decision
- 1994-02-02
Clearances · page 32 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K935211 | WALK N CHAIR | Brookefield Hunter, Inc. | IOR | Class I | 1994-02-02 |
| K925820 | ARTHRITIC HEAT WRAP | Conair Corp. | IRT | Class II | 1994-02-02 |
| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | Cardio Systems, Inc. | INX | Class II | 1994-02-02 |
| K931843 | HOT/ICE SYSTEM STERILE CONFORMABLE/DISP. BLANKETS | Hollister, Inc. | ILO | Class II | 1994-02-02 |
| K933443 | COMBI 2.5 INTERSEGMENTAL TRACTION TABLE | Williams Healthcare Systems, LLC | JFB | Class II | 1994-02-02 |
| K931555 | ARTROMOT K2 CPM | Ormed Mfg., Inc. | BXB | Class I | 1994-01-31 |
| K933726 | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM | Augustine Medical, Inc. | LHC | Class I | 1994-01-28 |
| K931736 | M-FLEX 5000 C3PMD | Medical Systems Corp. | BXB | Class I | 1994-01-27 |
| K933584 | SACRED CRANE TDP | Telstar Innovations, Inc. | ILY | Class II | 1994-01-27 |
| K933311 | MOTORIZED ELECTRIC PARALLEL BARS | Midland Mfg. Co. | BXB | Class I | 1994-01-26 |
| K926262 | FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE | Sgarlato Laboratories, Inc. | BXB | Class I | 1994-01-26 |
| K931723 | HYDRO-TRED/AIR POWERED TREADMILL | Santa FE Swim Systems | BXB | Class I | 1994-01-26 |
| K931819 | CARAPACE SUTURE REMOVAL TRAYS | Carapace, Inc. | IRO | Class I | 1994-01-26 |
| K932881 | OLYMPIC WARM-LAMP | Olympic Medical Corp. | ILY | Class II | 1994-01-26 |
| K934845 | SONICATOR 715 | Mettler Electronics Corp. | IMG | Class II | 1994-01-21 |
| K932916 | GALVANIC GENERATOR MODEL IMF4150/A | Biomedical Life Systems, Inc. | IPF | Class II | 1994-01-07 |
| K932739 | FAST START NEUROMUSCULAR STIMULATOR | Madeoutback Co. , Ltd. | IPF | Class II | 1994-01-07 |
| K934560 | WIZARD PEDIATRIC WHEELCHAIR | Snug Seat, Inc. | IOR | Class I | 1994-01-07 |
| K933621 | HILO TABLE | Spinalight, Inc. | INQ | Class I | 1994-01-07 |
| K934418 | BASIC TILT CHAIR ( BTC ) | Labac Systems, Inc. | IOR | Class I | 1994-01-07 |
| K933622 | FLEXION DISTRACTION TABLE | Spinalight, Inc. | INQ | Class I | 1994-01-07 |
| K935260 | PHYSIOMETRIX CABLE ADAPTER MODIFICATION | Physiometrix, Inc. | IKD | Class II | 1993-12-23 |
| K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | Medical Device Inspection Co., Inc. | IOQ | Class II | 1993-12-21 |
| K934646 | ACTION WIZARD PEDIATRIC MANUAL WHEELCHAIR | Invacare Corp. | IOR | Class I | 1993-12-15 |
| K933581 | POWERMATIC TREATMENT TABLE | Medical Device Inspection Co., Inc. | INQ | Class I | 1993-11-05 |
| K933580 | POWER WORK TABLE | Medical Device Inspection Co., Inc. | INQ | Class I | 1993-11-05 |
| K933578 | POWERMATIC MAT PLATFORM | Medical Device Inspection Co., Inc. | INQ | Class I | 1993-11-05 |
| K930634 | SUR FLO THERMAL THERAPY PADS | Buckman Co., Inc. | ILO | Class II | 1993-11-01 |
| K934263 | PORTABLE STANDARD | Cloverleaf Cycle Co. | IOR | Class I | 1993-11-01 |
| K934297 | DURABLE MEDICAL EQUIPMENT COMPANY, STANDARD MECHANICAL WHEELCHAIR | Durable Medical Equipment, Inc. | IOR | Class I | 1993-11-01 |
| K933072 | PCI 2500 | Pci | IPF | Class II | 1993-10-28 |
| K924237 | WINDMERE PRELUDE III | Windmere Corp. | ISA | Class I | 1993-10-18 |
| K930253 | CARDIO2 CTCKE | Ergometrx, Inc. | ISD | Class II | 1993-10-18 |
| K924973 | DYLNAMEDICS A.S.A.P. | Dynamedics, Inc. | INX | Class II | 1993-10-15 |
| K924582 | HEALTH ESSENTIALS BODY CARE MASSAGER | Conair Corp. | IRO | Class I | 1993-10-12 |
| K924519 | BODYTHERM | Conair Corp. | IRO | Class I | 1993-10-12 |
| K924583 | HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER | Conair Corp. | IRO | Class I | 1993-10-12 |
| K924518 | BODY SOOTHER | Conair Corp. | ISA | Class I | 1993-10-12 |
| K924885 | KING SIZE HEAT PAD | Conair Corp. | IRT | Class II | 1993-10-12 |
| K924799 | MOIST HEAT PAD | Conair Corp. | IRT | Class II | 1993-10-12 |
| K924800 | MOSIST HEAT PAD WITH AUTOMATIC OFF | Conair Corp. | IRT | Class II | 1993-10-12 |
| K933051 | ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION | General Components Intl., Inc. | KNN | Class I | 1993-10-12 |
| K924581 | HEALTH ESSENTIALS MAXI MASSAGER | Conair Corp. | IRO | Class I | 1993-10-12 |
| K924431 | HEALTLH ESSENTIALS PERSONAL MASSAGER | Conair Corp. | IRO | Class I | 1993-10-12 |
| K933119 | HI-LO TREATMENT TABLES | Tri W-G, Inc. | INQ | Class I | 1993-10-12 |
| K924584 | HEALTH ESSENTIALS FANCY PERSONAL MASSAGER | Conair Corp. | IRO | Class I | 1993-10-12 |
| K924315 | THE MASSAGER | Four Directions | LYG | Class I | 1993-10-08 |
| K931781 | JACE TRI-STIM DEVICE | Jace Systems, Inc. | IPF | Class II | 1993-10-08 |
| K933249 | DYNATRON 100 PLUS | Dynatronics Research Corp. | IPF | Class II | 1993-10-08 |
| K932937 | DYNATRON 800 | Dynatronics Corp. | IMG | Class II | 1993-10-08 |
| K933176 | NEUROTECH 2000 (NT2000) | Bmr Ent., Inc. | IPF | Class II | 1993-10-08 |
| K932764 | THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P) | Myo/Kinetic Systems, Inc. | IPF | Class II | 1993-10-01 |
| K932625 | STAIR ASSIST(TM) POWERED GRAB BAR TRANSPORT | Stair Assist Corp. | ILK | Class II | 1993-09-30 |
| K933919 | MICROLITE WHEELCHAIR | Morgan Technology, Inc. | IOR | Class I | 1993-09-30 |
| K933406 | TRAVEL EASE | Merits Health Products., Inc. | IOR | Class I | 1993-09-30 |
| K931086 | WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER | Windmere Corp. | IRO | Class I | 1993-09-30 |
| K924520 | BODY TRAINER | Conair Corp. | ISA | Class I | 1993-09-30 |
| K933000 | RECLINING GERI CHAIRS W/CASTERS & LAP TRAY | Winco, Inc. | INM | Class I | 1993-09-30 |
| K933577 | POWERMATIC EXAMINATION TABLE | Medical Device Inspection Co., Inc. | INQ | Class I | 1993-09-30 |
| K932610 | PCI 4000 | Pci | IPF | Class II | 1993-08-19 |
| K932596 | NT4-PLUS | Bmr Ent., Inc. | IPF | Class II | 1993-08-12 |
| K926410 | ULTRATONE 8+ & 20 | Bowater Research, Inc. | IPF | Class II | 1993-08-11 |
| K926510 | STAODYN EMS+2 | Staodyne, Inc. | IPF | Class II | 1993-08-11 |
| K932399 | THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P) | Myo/Kinetic Systems, Inc. | IPF | Class II | 1993-08-11 |
| K926265 | NEURO-CARE 1000 | Ems Northwest | IPF | Class II | 1993-08-03 |
| K920760 | PERI-K PAD COLD PACK | Baxter Healthcare Corp | IMD | Class I | 1993-07-29 |
| K932241 | ECONOMY HI-LOW MAT TABLES/ELECTRIC MODELS | Bailey Mfg. Co. | INQ | Class I | 1993-07-22 |
| K932236 | PRO. HI-LOW TABLE MODEL 9530 | Bailey Mfg. Co. | INQ | Class I | 1993-07-22 |
| K932239 | ELECTRIC TILT TABLE MODEL 9505 | Bailey Mfg. Co. | INQ | Class I | 1993-07-22 |
| K931751 | ZERO GRAVITY WHEELCHAIR | General Components Intl., Inc. | IOR | Class I | 1993-07-22 |
| K932231 | ECONOMY HI-LOW MAT TABLE #4110 THRU 4117 | Bailey Mfg. Co. | INW | Class I | 1993-07-22 |
| K930730 | DORMIE NECK SUPPORT SYSTEM | The Western Diagnostics Co. | IQK | Class I | 1993-07-22 |
| K932795 | HAVERICH ORTHOPAEDIC CYCLES | Haverich Ortho-Sport (Usa), Inc. | IOR | Class I | 1993-07-22 |
| K932235 | PRO. HI-LOW MAT TABLES #9610-9612 9620-9622 | Bailey Mfg. Co. | INQ | Class I | 1993-07-22 |
| K932232 | PROFESSONAL HI-LOW WORK TABLE MODEL 3400 | Bailey Mfg. Co. | INQ | Class I | 1993-07-22 |
| K932234 | PROFESSIONAL & ECONMY TILT TABLE 9500 9520 | Bailey Mfg. Co. | INW | Class I | 1993-07-22 |
| K932927 | SRX COMP ULTRALIGHT WHEELCHAIR | Medical Composite Technology, Inc. | IOR | Class I | 1993-07-22 |
| K932749 | MODEL M4501,M4502,M4503,M4504,M4505 TILT TABLE | Med Mart, Inc. | INQ | Class I | 1993-07-22 |
| K930691 | ACCUTRAC TRACTION UNIT | I-Rep, Inc. | ITH | Class II | 1993-07-22 |
| K932233 | ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405 | Bailey Mfg. Co. | INW | Class I | 1993-07-22 |
| K931349 | TMR-670 | Pride Health Care, Inc. | INO | Class II | 1993-07-22 |
| K926391 | ACCUFLEX DYNAMIC ELBOW ORTHOSIS | Regulatory & Marketing Services, Inc. | IQI | Class I | 1993-07-22 |
| K932237 | PRO. HI-LOW TREATMENT TABLES MODELS 4050,4070,4090 | Bailey Mfg. Co. | INQ | Class I | 1993-07-22 |
| K932184 | STERILE LEMAITRE GLOW 'N TELL TAPE | Vascutech, Inc. | KFX | Class II | 1993-07-22 |
| K932639 | MANUAL TILT RECLINE CHAIR (MTC) | Labac Systems, Inc. | IOR | Class I | 1993-07-22 |
| K932238 | ECO. HI-LOW TREATMENT TABLES VARIOUS MODEL NUMBERS | Bailey Mfg. Co. | INW | Class I | 1993-07-22 |
| K931635 | TREATMENT TABLES, MANUALLY ACTIVATED | Med Mart, Inc. | INW | Class I | 1993-07-21 |
| K925270 | EX N' FLEX EF-200 | Tecogics Scientific , Ltd. | BXB | Class I | 1993-07-21 |
| K932480 | PRISM | Bio Clinic Co. | IOQ | Class II | 1993-07-21 |
| K932412 | TREATMENT TABLES, ELECTRICALLY ACTIVATED | Med Mart, Inc. | INQ | Class I | 1993-07-21 |
| K932746 | MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE | Tri W-G, Inc. | INQ | Class I | 1993-07-21 |
| K930186 | INTERTRON 6000/6100 | Williams Healthcare Systems, LLC | IMI | Class II | 1993-07-02 |
| K930328 | NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT | Bio-Logic Systems Corp. | IKN | Class II | 1993-07-02 |
| K930670 | PHYACTION 787 | Verimed Holdings, Inc. | IPF | Class II | 1993-07-02 |
| K930307 | INTELECT 222 P | Chattanooga Group, Inc. | IMI | Class II | 1993-07-02 |
| K922839 | MID-CANADA MEDICAL | Mid-Canada Medical | IMI | Class II | 1993-07-02 |
| K922036 | SONOPULS 591 | Henley Intl. | IMG | Class II | 1993-06-29 |
| K931832 | THE HILL ADJUSTABLE HA90 | Hill Laboratories Co. | INQ | Class I | 1993-06-29 |
| K925036 | HANDY VIBRO BELT | Cosmesearch, Inc. | ISA | Class I | 1993-06-29 |
| K925054 | INFRARED LAMP | Lumiscope Co., Inc. | ILY | Class II | 1993-06-29 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.