Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 26
- Latest Decision
- 1995-10-13
Clearances · page 28 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K954261 | LANDEEZ ALL-TERRAIN WHEELCHAIR | Natural Access | IOR | Class I | 1995-10-13 |
| K954344 | RUSSON INDUSTRIES FURNITURE QUALITY WHEELCHAIR | Russon Industries | IOR | Class I | 1995-10-13 |
| K954044 | SIDEKICK POWER WHEELCHAIR | 21st Century Scientific, Inc. | ITI | Class II | 1995-10-13 |
| K954117 | CUSTOMCARE SEATING SYSTEM | Span-America Medical Systems, Inc. | KIC | Class I | 1995-10-13 |
| K950617 | SMART WAVE GS100 | Shotwell & Carr, Inc. | IPF | Class II | 1995-10-13 |
| K942965 | COMPUTER DYNO/GONIO/MYO GRAPHY | Infotronic Medical Engineering | IKN | Class II | 1995-10-07 |
| K945853 | THERMOTEK H-300 | Thermotek, Inc. | ILO | Class II | 1995-10-05 |
| K953541 | INSTANT COLDGEL | Prism Technologies, Inc. | IMD | Class I | 1995-10-05 |
| K950755 | FLEXMATE K500 | Breg, Inc. | BXB | Class I | 1995-10-05 |
| K953532 | EBICE | Electro-Biology, Inc. | ILO | Class II | 1995-10-04 |
| K951916 | CC RIDER, MODEL ME180 | Mettler Electronics Corp. | IKK | Class II | 1995-10-04 |
| K952990 | SPIN ROLLERE | Kinsei Shiatsu, Inc. | ISA | Class I | 1995-09-29 |
| K952655 | B & L ELECTRODE | B & L Engineering | IKN | Class II | 1995-09-28 |
| K951029 | HAMEX ONE | Northern Orthopaedic Products, Inc. | BXB | Class I | 1995-09-15 |
| K945733 | AQUAHAB, MODEL 120-72-101 | Aquarius Electronics, Inc. | BXB | Class I | 1995-09-15 |
| K950682 | W2 WRIST CPM UNIT | Toronto Medical Corp. | BXB | Class I | 1995-09-13 |
| K953622 | PTT 6200 ELEVATION THERAPY TABLE | U.S. Table, Inc. | INQ | Class I | 1995-09-11 |
| K943244 | DEUCE | Apt Technology, Inc. | IQA | Class II | 1995-09-11 |
| K953342 | TMR48 | Pride Health Care, Inc. | INO | Class II | 1995-09-08 |
| K950376 | PARKER MODEL PM | Parker Treadmill Co., Inc. | IOL | Class I | 1995-09-06 |
| K950377 | PARKER MODEL PE | Parker Treadmill Co., Inc. | IOL | Class I | 1995-09-06 |
| K952043 | BACK MASSAGER | Eight Corners, Inc. | LYG | Class I | 1995-09-01 |
| K930665 | CENTURY BATHING SYSTEM | Arjo-Century, Inc. | ILJ | Class II | 1995-08-28 |
| K952916 | SHIATSU MASTER MASSAGER CUSHION | Kinsei Shiatsu, Inc. | IRO | Class I | 1995-08-28 |
| K950680 | INFANT HEEL WARMER | Baxter Healthcare Corp | IMD | Class I | 1995-08-23 |
| K950395 | THERMOCOOL SYSTEM | Zimmer, Inc. | ILO | Class II | 1995-08-18 |
| K952041 | BODYFLEX MASSAGER | Truro'S Ent. | ISA | Class I | 1995-08-14 |
| K946186 | CHAL-2500 | Hogan & Hartson | IPF | Class II | 1995-08-14 |
| K943185 | BX-200 SC | Bloomex International, Inc. | IPF | Class II | 1995-08-14 |
| K942195 | BX-400S | Bloomex International, Inc. | IPF | Class II | 1995-08-14 |
| K951414 | CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR | Champion Mfg. Corp. | IRO | Class I | 1995-08-11 |
| K951771 | COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM | Sms Technologies, Ltd. | KHX | Class I | 1995-08-11 |
| K952112 | AMIGO GRAND TOUR | Amigo Mobility Intl., Inc. | INI | Class II | 1995-08-11 |
| K945047 | BCW 600 POWER WHEELCHAIR | Wheelchairs of Kansas | ITI | Class II | 1995-08-11 |
| K950724 | MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS | Invacare Corp. | ITI | Class II | 1995-08-07 |
| K952369 | KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE | Physicians Consulting, Inc. | BXB | Class I | 1995-08-07 |
| K946229 | BALANCE MANAGER | Neurocom International, Inc. | KHX | Class I | 1995-08-04 |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | ISA | Class I | 1995-08-02 |
| K953427 | CHAMPION, 3000 REBEL | Kuschall of America | IOR | Class I | 1995-07-31 |
| K943433 | TOTAL CONTACT SEAT RIPPLE SYSTEM | Numotech, Inc. | IOQ | Class II | 1995-07-31 |
| K953426 | COMPETITOR | Kuschall of America | IOR | Class I | 1995-07-31 |
| K953428 | CHAMPION, 3000 | Kuschall of America | IOR | Class I | 1995-07-31 |
| K953429 | CHAMPION, 1000 | Kuschall of America | IOR | Class I | 1995-07-31 |
| K950441 | CONAIR FAMILY FITNESS BODY ENERGY | Conair Corp. | IRO | Class I | 1995-07-18 |
| K950085 | MULTICURE(R) S GEL PAD | Multigestion (Deutschland) GmbH | KIC | Class I | 1995-07-13 |
| K944787 | INTEGRATED MOVEMENT ANALYZER | Maryrose | IKN | Class II | 1995-07-07 |
| K950711 | T-350 THERAPEUTIC COOLING MACHINE | Thermotek, Inc. | ILO | Class II | 1995-07-06 |
| K952641 | QUICKIE TSR | Sunrise Medical, Inc. | IOR | Class I | 1995-07-06 |
| K952357 | THE HILL ADJUSTABLE PODIATRY MODEL | Hill Laboratories Co. | INQ | Class I | 1995-07-06 |
| K951419 | FLEX D-4000 | U.S. Table, Inc. | INQ | Class I | 1995-06-30 |
| K951001 | FLEXICAIR EXLIPSE | Hill-Rom, Inc. | IOQ | Class II | 1995-06-27 |
| K944935 | DYNATRON 250 | Dynatronics Corp. | IPF | Class II | 1995-06-22 |
| K952355 | THE HILL ADJUSTABLE 90MD | Hill Laboratories Co. | INQ | Class I | 1995-06-22 |
| K942109 | THE HILL ADJUSTABLE RATH MECHANICAL TABLE | Hill Laboratories Co. | INQ | Class I | 1995-06-22 |
| K951955 | CARDON PHYSICAL THERAPY TABLE MODEL:R40194 | Cardon Rehabilitation Products, Inc. | INQ | Class I | 1995-06-22 |
| K952358 | THE HILL ADJUSTABLE P.T. MOBILIZATION TABLE | Hill Laboratories Co. | INQ | Class I | 1995-06-22 |
| K945690 | BACKCYCLER CPM(TM) | Ergomedics, Inc. | BXB | Class I | 1995-06-22 |
| K952359 | THE HILL ADJUSTABLE HA90C | Hill Laboratories Co. | INQ | Class I | 1995-06-22 |
| K952356 | THE HILL ADJUSTABLE COUNTERSTRAIN TABLE | Hill Laboratories Co. | INQ | Class I | 1995-06-22 |
| K952431 | SPECTRUM | Freedom Designs, Inc. | IOR | Class I | 1995-06-22 |
| K951621 | J & S WHEELCHAIRS MODELS 500, 500B, 502, 503, 504 AND 500T | J&S Associates | IOR | Class I | 1995-06-22 |
| K942256 | THE HILL ADJUSTABLE EXTEND-R TABLE | Hill Laboratories Co. | INQ | Class I | 1995-06-22 |
| K952600 | EVT-5000BX | U.S. Table, Inc. | INQ | Class I | 1995-06-22 |
| K952069 | MECHANICAL WHEELCHAIR | Grand Seating King Corp. | IOR | Class I | 1995-06-22 |
| K951746 | FORTE CB | Chattanooga Group, Inc. | IMG | Class II | 1995-06-21 |
| K950095 | CYBEX 770 | Cybex | IKK | Class II | 1995-06-21 |
| K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | American Hydro-Surgical Instruments, Inc. | LHC | Class I | 1995-06-20 |
| K945468 | T-300 COOLER | Temptek, Inc. | ILO | Class II | 1995-06-19 |
| K952441 | LEGEND | Health Care Mfg., Inc. | INQ | Class I | 1995-06-19 |
| K951906 | CARDON PHYSICAL THERAPY TABLES MODELS R28591 & R28592 | Cardon Rehabilitation Products, Inc. | INQ | Class I | 1995-06-15 |
| K946169 | ACTIC 2002 | North Atlantic Rehabilitation, Inc. | BXB | Class I | 1995-06-15 |
| K951323 | VH-2000 | Health Care Mfg., Inc. | INQ | Class I | 1995-06-07 |
| K944596 | GRAHAM-FIELD ULTRASOUND LOTION | Chester Labs, Inc. | IMI | Class II | 1995-06-07 |
| K943497 | CONTRAST 7000 THERAPY SYSTEM | Burke Neutech, Inc. | ILO | Class II | 1995-06-07 |
| K951382 | HLT 406 | Health Care Mfg., Inc. | INQ | Class I | 1995-06-01 |
| K951383 | TEMPRA HEAT PACK | Tempra Technology, Inc. | IMD | Class I | 1995-06-01 |
| K951952 | CARDON PHYSICAL THERAPY TABLE MODEL R27112 | Cardon Rehabilitation Products, Inc. | INQ | Class I | 1995-05-31 |
| K951954 | CARDON PHYSICAL THERAPY TABLE MODEL R27108 | Cardon Rehabilitation Products, Inc. | INQ | Class I | 1995-05-31 |
| K951953 | CARDON PHSICAL THERAPY TABLE MODEL R27630 | Cardon Rehabilitation Products, Inc. | INQ | Class I | 1995-05-31 |
| K950756 | PULMONEX DYNAMIC AIR THERAPY UNIT | Hill-Rom, Inc. | IKZ | Class II | 1995-05-30 |
| K946382 | SKALPI 3200 | Wiscco Development, Inc. | IRO | Class I | 1995-05-30 |
| K944699 | ATT-300 | Health Care Mfg., Inc. | ITH | Class II | 1995-05-26 |
| K950872 | CARDON PHYSICAL THERAPY TABLE MODEL: R27841 | Cardon Rehabilitation Products, Inc. | INQ | Class I | 1995-05-25 |
| K950410 | CONAIR BODY AND SOLE | Conair Corp. | IRO | Class I | 1995-05-23 |
| K951228 | ASH-7000 | U.S. Table, Inc. | ITH | Class II | 1995-05-17 |
| K950681 | MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY | Invacare Corp. | IKZ | Class II | 1995-05-16 |
| K950564 | RICH-MAR US-II ULTRASOUND | Rich-Mar Corp. | IMI | Class II | 1995-05-15 |
| K945175 | MECHANICAL WHEELCHAIR 890.3850 | Lumex, Inc. | IOR | Class I | 1995-05-12 |
| K945150 | MECHANICAL WHEERCHAIR- ECLIPSE | Colours 'N Motion | IOR | Class I | 1995-05-12 |
| K945153 | MECHANICAL WHEELCHAIR- LIL DIPPER | Colours 'N Motion | IOR | Class I | 1995-05-12 |
| K945148 | MECHANICAL WHEELCHAIR- AVENGER | Colours 'N Motion | IOR | Class I | 1995-05-12 |
| K945149 | MECHANICAL WHEELCHAIR- CHALLENGER | Colours 'N Motion | IOR | Class I | 1995-05-12 |
| K950815 | CHAMPION | Kleinfeld, Kaplan and Becker | IOR | Class I | 1995-05-12 |
| K945151 | MECHANICAL WHEELCHAIR- G-FORCE | Colours 'N Motion | IOR | Class I | 1995-05-12 |
| K951847 | AVANTGARDE | Otto Bock Orthopedic Industry, Inc. | IOR | Class I | 1995-05-12 |
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | Burke Neutech, Inc. | JFA | Class I | 1995-05-11 |
| K946298 | BIOSTIM-HV | Progressive Concepts, Inc. | IPF | Class II | 1995-05-11 |
| K932075 | MASTERSTIM 1-4 | Health Care Assoc. | IPF | Class II | 1995-05-10 |
| K944909 | WAHL FRESH FACE | Wahl Clipper Corp. | IRO | Class I | 1995-05-08 |
| K945508 | FX-2P NMS (2 CHANNEL PORTABLE) | Fx-2 | IPF | Class II | 1995-05-02 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.