meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
31
Latest Decision
1998-10-25

Clearances · page 25 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983639 ZIPPIE GS, MODEL # EIZGS Sunrise Medical, Inc. IOR Class I 1998-10-25
K974395 ATLANT'S Grad-Line Corp. IRP Class II 1998-10-22
K981004 SLE EMG ELECTRODES AND ACCESSORIES Specialized Laboratory Equipment, Ltd. IKT Class II 1998-10-21
K965136 UROSURGE UROTHERM FLUID WARMING SYSTEM Princeton Regulatory Assoc. LHC Class I 1998-10-16
K982425 CODA MPX30 MOTION ANALYSIS SYSTEM Pinsco Inc. Dba B & L Engineering LXJ Class II 1998-10-07
K982064 ACTION STORM RANGER II, ACTION STORM POWER 9000 Invacare Corp. ITI Class II 1998-10-05
K982849 PANTHER WHEELCHAIR Snug Seat, Inc. IOR Class I 1998-10-05
K982099 MOMENTUM NO. FS008 WHEELCHAIR Sriram Enterprises D.B.A. Momentum Group IOR Class I 1998-10-05
K982989 QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR Sunrise Medical, Inc. IOR Class I 1998-10-05
K982482 HANDMASTER NMS1 N.E.S.S. Nuromuscular Electrical Stimulation Syst IPF Class II 1998-09-30
K982546 PHASER-2000 Diomedics, Inc. ILY Class II 1998-09-22
K981563 BIOPAK MEASUREMENT SYSTEM Bio-Research Associates, Inc. KZM Class II 1998-09-15
K982388 SURGI STIM Vision Quest Industries, Inc. IPF Class II 1998-09-14
K964977 IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1) Interactive Living Systems, Inc. LFF Class I 1998-08-31
K982066 MP-3 POWER BASE CHAIR Merits Health Products., Inc. ITI Class II 1998-08-31
K982158 SCOUT Burke, Inc. ITI Class II 1998-08-31
K982607 MANUAL WHEELCHAIR G. Hirsch and Co., Inc. IOR Class I 1998-08-31
K982336 KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS Invacare Corp. IOR Class I 1998-08-21
K980909 VICHY SHOWER Bouvier Hydro, Inc. ILJ Class II 1998-08-11
K980158 MYO-TRAIN V (5) Sterne Equipment Co., Ltd. IPF Class II 1998-07-28
K980920 EQUINOXE Bouvier Hydro, Inc. ILJ Class II 1998-07-16
K980040 ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D Nisha Communication Industries IPF Class II 1998-07-13
K981558 MYCYCLE HANDMASTER, LIGHT Richvale , Ltd. IOR Class I 1998-07-09
K981557 MYCYCLE, HANDMASTER, VICTORY Richvale , Ltd. IOR Class I 1998-07-09
K981837 TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS Motion Concepts ITI Class II 1998-07-09
K981486 STAIR-LIFT Garaventa (Canada) , Ltd. ING Class II 1998-07-01
K981121 AMIGO RT Amigo Mobility Intl., Inc. INI Class II 1998-06-30
K981822 DRS SYSTEM Professional Distribution Systems, Inc. ITH Class II 1998-06-24
K974321 HYDROTONE North American Technical Services Corp. ILJ Class II 1998-06-22
K974468 PHOTONIC STIMULATOR Bales Scientific, Inc. ILY Class II 1998-06-22
K981422 TC SERIES Get A Life-Give A Living Plus Kids Project, Inc. IOR Class I 1998-06-10
K981419 TC SERIES (TILT RECLINER) Get A Life-Give A Living Plus Kids Project, Inc. IOR Class I 1998-06-10
K981421 TC SERIES (RECLINER) Get A Life-Give A Living Plus Kids Project, Inc. IOR Class I 1998-06-10
K981420 TC SERIES (WIDE) Get A Life-Give A Living Plus Kids Project, Inc. IOR Class I 1998-06-10
K981418 TC SERIES (TRANSPORT) Get A Life-Give A Living Plus Kids Project, Inc. IOR Class I 1998-06-10
K973929 NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM Neotonus, Inc. IPF Class II 1998-05-21
K980892 HAKOMED ELECDT / PRO ELEDT SERIES Alive, Inc. IPF Class II 1998-05-11
K980958 HAKOMED ELECDT/VACUPULLS Alive, Inc. IPF Class II 1998-05-11
K980021 EXTENTRAC Advanced Back Technologies JFB Class II 1998-05-11
K972419 TOENNIES NEUROSCREEN SYSTEM Erich Jaeger, Inc. IKN Class II 1998-04-30
K980346 ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) Universal Technology Systems, Inc. IPF Class II 1998-04-28
K980033 FERNO HEALTHCARE RECLINE-A-BATH 2 Ferno-Washington, Inc. ILJ Class II 1998-04-21
K980607 DERMATHERM 100 New Star Lasers, Inc. ILY Class II 1998-04-03
K980448 MODEL PS-1 PENA MUSCLE STIMULATOR Radionics, Inc. IPF Class II 1998-04-03
K980718 PARA-CARE Chattanooga Group, Inc. IMC Class II 1998-03-27
K974855 PHORESOR II, MODEL PM900 Iomed, Inc. KTB Class II 1998-03-27
K980769 WINDMERE MODEL DS-2 FOOT BATH Windmere Corp. ILJ Class II 1998-03-27
K980509 DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS Deroyal Industries, Inc. IMD Class I 1998-02-26
K971593 SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT The Silcraft Corp. ILJ Class II 1998-02-26
K971592 XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM The Silcraft Corp. ILJ Class II 1998-02-26
K973373 PREVENT I The Buzzz Corp. INO Class II 1998-02-26
K972486 PRESSUREGUARD IV Span-America Medical Systems, Inc. IKZ Class II 1998-02-20
K980107 RUNCH INDUSTRIAL WHEELCHAIR Runch Group USA, Inc. IOR Class I 1998-02-19
K974385 MLS ELECTROMYOGRAPHIC PREAMPLIFIER Motion Lab Systems, Inc. IKN Class II 1998-02-19
K973223 STELLAR MODEL HS-04 Stellar Medical Corp. IPF Class II 1998-02-18
K974626 P.T. MACHINE Goodman, Goodman & Goodman JFB Class II 1998-02-06
K972111 RUMORS DYNAMIC AIR THERAPY UNIT Hill-Rom, Inc. IKZ Class II 1998-02-02
K974820 BREEZY SERIES Sunrise Medical, Inc. IOR Class I 1998-01-27
K973732 MEGAPULSE II Pti IMJ Class II 1998-01-23
K973624 NURSE'S AID PATIENT ROTATION SYSTEM Air Med Assist Products IOQ Class II 1998-01-21
K972176 HOME CARE BEAD BED Kinetic Concepts, Inc. INX Class II 1998-01-16
K974010 ADVANTAGE EMG SYSTEM, MODEL #A100 Advantage Medical Division of Cme Telemetrix IKN Class II 1998-01-16
K972851 ZIPPY Pillar Technology, Inc. ITI Class II 1998-01-08
K973951 LEVO COMPACT-EASY LCE Levo USA IPL Class II 1997-12-23
K963817 LEVO MOBIL LCM Levo USA IPL Class II 1997-12-23
K974197 ELITE LIGHTWEIGHT WHEELCHAIR Jaken Co., Inc. IOR Class I 1997-12-17
K973355 ADVANTAGE 3000 Advantage Medical Division of Cme Telemetrix IKN Class II 1997-12-05
K973491 MECHANICAL FOLDING WHEEL CHAIR Heartway Medical Products Co., Ltd. IOR Class I 1997-12-04
K972230 QUICKIE P90 SERIES Quickie Designs, Inc. ITI Class II 1997-12-02
K973444 TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES Medelec, Inc. D.B.A. Teca Corp. IKT Class II 1997-11-20
K973673 QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES Sunrise Medical, Inc. IOR Class I 1997-11-20
K973442 TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES Medelec, Inc. D.B.A. Teca Corp. IKT Class II 1997-11-20
K973529 NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES Medicotest A/S IKT Class II 1997-11-20
K974190 CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER Consolidated Products & Services, Inc. IMD Class I 1997-11-19
K970363 HYDROTEC LOW AIR LOSS THERAPY BED Apex Metal, Inc. IOQ Class II 1997-11-17
K970364 AIRTEC2 LOW AIR LOSS THERAPY BED Apex Metal, Inc. IOQ Class II 1997-11-17
K972370 RASCAL POWER CHAIR Electric Mobility, LLC ITI Class II 1997-11-14
K973770 ALLEGIANCE KWIK HEAT WARM PERINEAL PACK Allegiance Healthcare Corp. IMD Class I 1997-11-13
K973024 INTELECT LEGEND ULTRASOUND Chattanooga Group, Inc. IMI Class II 1997-11-10
K972997 AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION Dan Med, Inc. IPF Class II 1997-11-10
K964397 THERAPIK The Jenex Corporation ILY Class II 1997-11-04
K955808 DYNA T-2000 PHYSICAL THERAPY SYSTEM Thermia, Inc. IMB Class II 1997-11-03
K973023 INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET Hollister, Inc. ILO Class II 1997-11-03
K973031 STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE R. Thomas Grotz, M.D., Inc. MRI Class I 1997-11-03
K964926 BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC Joerns Healthcare, Inc. ILJ Class II 1997-11-03
K972093 REGENESIS MODEL 42 Regenesis Biomedical, Inc. ILX Class II 1997-10-21
K973418 UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) Assembly Required Dist., Inc. IOR Class I 1997-10-09
K964434 SD-970EMS ELECTRICAL MUSCULAR STIMULATOR Skylark Device Co., Ltd. IPF Class II 1997-10-09
K973473 ASLI Texin Industrial (International) , Ltd. IOR Class I 1997-09-26
K961751 W.M.E. GPS 1001 Weaver Medical Electronics, Inc. IPF Class II 1997-09-25
K971046 HANDIFLEX Handiflex Corp. JFB Class II 1997-09-16
K970847 IMPULSE HVG Armstrong Industries, Inc. IPF Class II 1997-09-10
K970197 HTP-1500 LOCALIZED HEAT THERAPY PUMP Adroit Medical Systems, Inc. ILO Class II 1997-09-10
K972055 MSI MAGNA-STYM Microvas Systems, Inc. IPF Class II 1997-08-29
K964354 ARTOCOOL-S WATER CIRCULATING COLD PACK Ormed GmbH ILO Class II 1997-08-29
K964799 ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY Ormed GmbH ILO Class II 1997-08-29
K970927 BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM Bruno Independent Living Aids, Inc. ILK Class II 1997-08-26
K970636 TOTALCARE., MODULAR THERAPY SYSTEM (MTS) Hill-Rom, Inc. IOQ Class II 1997-08-26
K972564 TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT Mechanical Application Designs, Inc. ITI Class II 1997-08-25
K970646 SAFARI Ranger All Season Corp. INI Class II 1997-08-25

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