meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
27
Latest Decision
1997-08-25

Clearances · page 26 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K972147 PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2) Dynamic Systems, Inc. ITI Class II 1997-08-25
K972563 LIFT MASTER Mechanical Application Designs, Inc. ITI Class II 1997-08-22
K971117 WARMETTE Olympic Medical Corp. LHC Class I 1997-08-22
K971542 ORTHO DX NEUROMUSCULAR STIMULATOR Rehabilicare, Inc. IPF Class II 1997-08-14
K972797 TOOL-LESS WHEEL CHAIR Sunrise Medical, Inc. IOR Class I 1997-08-12
K970575 ELECTRO-LITE ELITE POWERED WHEELCHAIR Damaco ITI Class II 1997-08-05
K971043 GOLDEN EAGLE Golden Technologies, Inc. INI Class II 1997-08-01
K971050 GOLDEN HAWK Golden Technologies, Inc. INI Class II 1997-08-01
K971387 FREERIDER, MODEL FR510-F Freerider USA, Inc. INI Class II 1997-07-23
K971388 FREERIDER, MODEL FR168-4 Freerider USA, Inc. INI Class II 1997-07-23
K965123 PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE) Burke, Inc. INI Class II 1997-07-17
K971873 LEVO ACTIVE-EASY LAE Levo USA IPL Class II 1997-07-03
K972038 INTRUDER The Buzzz Corp. INI Class II 1997-07-03
K964873 SILKAIR LOW AIRLOSS THERAPY Hill-Rom, Inc. IOQ Class II 1997-07-03
K972037 PROWLER The Buzzz Corp. INI Class II 1997-07-03
K972036 STEALTH The Buzzz Corp. INI Class II 1997-07-03
K970543 BOBCAT DX Quest Enabling Designs , Ltd. IPL Class II 1997-06-26
K970131 ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE C.L. Mcintosh & Assoc., Inc. IMI Class II 1997-06-16
K970592 N/A North American Technical Services Corp. ILY Class II 1997-06-13
K970590 N/A North American Technical Services Corp. ILY Class II 1997-06-13
K970523 SOLO Ranger All Season Corp. INI Class II 1997-06-03
K970491 DUPEL II BUFFERED IONTOPHORESIS ELECTRODES Empi EGJ Class II 1997-05-30
K964223 CLINITRON RITE-HITE Hill-Rom, Inc. INX Class II 1997-05-28
K970295 FLEXICAIR EXLIPSE PLUS Hill-Rom, Inc. IOQ Class II 1997-05-16
K970094 MODEL DX MICRO COMPUTER CONTROL Invacare Respiratory Corp. ITI Class II 1997-05-12
K954577 WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS C.A.I. Industries Corp. ILY Class II 1997-05-09
K964710 BLEDSOE COLD CONTROL Med Technology, Inc. ILO Class II 1997-05-09
K971389 ECLIPSE 400 MANUALLY OPERATED WHEELCAIR Pdg Product Design Group, Inc. IOR Class I 1997-05-09
K962788 CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM Gaymar Industries, Inc. IKZ Class II 1997-04-30
K960951 PERMOBIL CHAIRMAN L/CS 8 Permobil AB ITI Class II 1997-04-30
K970743 BCW POWER ADVANTAGE WHEELCHAIR Wheelchairs of Kansas ITI Class II 1997-04-30
K964208 MD-1A GALVANIC UNIT R. A. Fischer Co. Corp. EGJ Class II 1997-04-30
K963382 QUICKIE P100 SERIES Quickie Designs, Inc. ITI Class II 1997-04-28
K971142 ADVENTURER T.E.S., Ltd. IOR Class I 1997-04-28
K963385 QUICKIE POWER WHEELCHAIRS P200 SERIES Quickie Designs, Inc. ITI Class II 1997-04-28
K963381 QUICKIE P300 SERIES Quickie Designs, Inc. ITI Class II 1997-04-28
K955666 EGS4000 S&P Electrical Industries, Inc. IPF Class II 1997-04-15
K970533 MODEL 1100 COLD THERAPY DEVICE Smith & Nephew, Inc. ILO Class II 1997-04-15
K970164 ROLL AID Stand Aid of Iowa, Inc. ITI Class II 1997-04-15
K964083 ULTRATHERM (908) Sie-Med, Inc. IMJ Class II 1997-04-03
K970399 KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) Allegiance Healthcare Corp. IMD Class I 1997-04-03
K963887 PT-PAC PORTABLE HEATING PAD Anthony A. Chiurco IRT Class II 1997-03-31
K970521 TRX POWER TILT AND RECLINE SYSTEM Motion Concepts ITI Class II 1997-03-31
K962565 POWERED WHEELCHAIR Orthofab, Inc. ITI Class II 1997-03-20
K964954 SUPERLIGHT Wheelcare Scooters, Inc. INI Class II 1997-03-20
K964932 ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR L & M Resource Information Service, Inc. IOR Class I 1997-03-17
K970155 NEURO-TRAIN II (2) Sterne Equipment Co., Ltd. IPF Class II 1997-03-17
K964957 INTERMITTENT COMPRESSOR SYSTEM Eischoco, Inc. IRP Class II 1997-02-24
K962243 VASOTHERM Ehti Medical Corp. IMJ Class II 1997-02-21
K962703 THEE THERMASTIM Ehti Medical Corp. IMJ Class II 1997-02-21
K970311 BENTLEY MANUALLY OPERATED WHEELCHAIR Pdg Product Design Group, Inc. IOR Class I 1997-02-14
K963808 CHOICE POWERED WHEELCHAIR American Medical Technology, Inc. ITI Class II 1997-02-12
K964523 RECOVER INFANT HEEL WARMER (5100) Florida Medical Industries, Inc. MPO Class I 1997-02-10
K964028 SYS STIM 226 Mettler Electronics Corp. IPF Class II 1997-02-03
K964423 AXIOM INF Axiom Manufacturing IPF Class II 1997-01-24
K963479 WHEELCHAIR BELT Deroyal Industries, Inc. KID Class I 1997-01-24
K963480 MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER Deroyal Industries, Inc. KID Class I 1997-01-22
K963475 PONCHO VEST RESTRAINT Deroyal Industries, Inc. KID Class I 1997-01-22
K964682 SKYWAY Kid'S Wheel-Chairs IOR Class I 1997-01-13
K962983 STERILE SOFT-TEMP Adroit Medical Systems, Inc. ILO Class II 1997-01-10
K963091 VOLLMAN PRONE POSITIONER Hill-Rom, Inc. IPT Class I 1997-01-09
K964006 INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) Hollister, Inc. ILO Class II 1996-12-31
K964134 TRUS<T>LIFT PORCH LIFT Trus T Lift ING Class II 1996-12-31
K964057 INCARE HOT/ICE SYSTEM SHOULDER BLANKET Hollister, Inc. ILO Class II 1996-12-31
K961013 DISPOSABLE NEEDLE ELECTRODE Medelec Intl. Corp. IKT Class II 1996-12-20
K962583 CAT SCOOTER WITH DS60 VONYTOLLRT Invacare Respiratory Corp. INI Class II 1996-12-18
K963689 RECOVER ADULT VEIN WARMER Florida Medical Industries, Inc. IMD Class I 1996-12-12
K963728 THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS China Chongqing Bashan Instrument Factory ILY Class II 1996-12-12
K963824 LI'S ITCH STOPPER Hontech Foundation For Medical Technology IRT Class II 1996-12-12
K962855 ULE-2, MULE-2, HAND ACCESSORY KIT Penny and Giles Biometrics , Ltd. ISD Class II 1996-12-11
K950550 XH-1 NEUROMUSCULAR STIMULATOR California Medical Research Institute IPF Class II 1996-12-04
K962591 FOOT WEIGHT ALARM Cleveland Medical Devices, Inc. IRN Class II 1996-12-04
K963596 POLAR CARE 300 Breg, Inc. ILO Class II 1996-12-04
K962195 HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 Sunbeam Health Division IRT Class II 1996-11-27
K962537 INCARE HOT/ICE LITE MACHINE Hollister, Inc. ILO Class II 1996-11-27
K963704 MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE Shippert Medical Technologies Corp. LYG Class I 1996-11-26
K962252 HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 Sunbeam Health Division IRT Class II 1996-11-25
K963768 INSTANT HOT PACKS Kick Ice, Inc. IMD Class I 1996-11-25
K962038 PES HOT/COLD COMPRESS Princeton Electronic Systems, Inc. IRT Class II 1996-11-13
K955274 BOOSTER LITE 3 MOTORIZED SCOOTER Optimed Technologies, Inc. INI Class II 1996-11-04
K955275 BOOSTER TROPHY 5 MOTORIZED SCOOTER Optimed Technologies, Inc. INI Class II 1996-11-04
K955276 BOOSTER LITE 4 MOTORIZED SCOOTER Optimed Technologies, Inc. INI Class II 1996-11-04
K961621 THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM Therapy Concepts, Inc. ILO Class II 1996-10-31
K963666 INSTANT COLD PACK Kick Ice, Inc. IMD Class I 1996-10-30
K963816 LEVO COMPACT LC Levo USA IPL Class II 1996-10-30
K961426 BIO BOOST Bio Compression Systems, Inc. IRP Class II 1996-10-28
K961425 BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS Bio Compression Systems, Inc. ILO Class II 1996-10-28
K961888 PILLAR 4-WHEEL SCOOTER Pillar Technology, Inc. INI Class II 1996-10-23
K963301 STANDARD WHEELCHAIR L & M Resource Information Service, Inc. IOR Class I 1996-10-23
K963459 SUPPORT VEST Skil-Care Corp. KID Class I 1996-10-15
K963461 SAFETY PONCHO/SHOULDER STRAP PONCHO Skil-Care Corp. KID Class I 1996-10-11
K963220 TEMPRA COLD PACK, REORDER NO. TC150 Tempo Technology, Inc. IMD Class I 1996-10-10
K963455 SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL Skil-Care Corp. KID Class I 1996-10-08
K962278 SUPERSTAND STAND-UP WHELLCHAIR The Standing Co., Inc. IPL Class II 1996-10-02
K923880 ORLAU SWIVEL WALKER Mopac, Ltd. MRI Class I 1996-09-30
K963261 EBI THERMAL THERAPY SYSTEM Electro-Biology, Inc. ILO Class II 1996-09-27
K952975 ANKLE CALF EXERCISER PHLEBOPUMP Prevent Products, Inc. BXB Class I 1996-09-25
K962462 MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR Smith and Nephew Donjoy, Inc. IPF Class II 1996-09-23
K955548 CHIPS POWERED WHEELCHAIR International Healthcare Solutions, Inc. ITI Class II 1996-09-20
K955547 CHIPS STANDUP WHEELCHAIR International Healthcare Solutions, Inc. ITI Class II 1996-09-20

5,661 clearances in the Physical Medicine panel. Data: openFDA.