meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
34
Latest Decision
1995-05-02

Clearances · page 29 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945510 FX-4 NMS (4CHANNEL TABLE MODEL) Fx-2 IPF Class II 1995-05-02
K945509 FX-2 NMS (2CHANNEL TABLE MODEL) Fx-2 IPF Class II 1995-05-02
K945152 MECHANICAL WHEELCHAIR- IMPACT Colours 'N Motion IOR Class I 1995-05-01
K935368 STC DIAGNOSTIC 8000 Sherman Technology Corp. IKN Class II 1995-05-01
K945467 BABYTHERM 8000 WB Drager, Inc. ILO Class II 1995-04-28
K951351 X2000 TRADITIONAL WHEELCHAIR Homecrest Industries IOR Class I 1995-04-26
K945257 577ES (ERGOSENSE) Lumex, Inc. INO Class II 1995-04-26
K934262 HPRH HOSPITAL PATIENT RADIANT HEATER Marley Electric Heating Co. ILO Class II 1995-04-18
K951560 RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) Radius Intl., Inc. IOR Class I 1995-04-17
K944481 THE HEART PROTECTOR Garan Scientific, Inc. NXB Class I 1995-04-10
K951120 SUN-BURST Kid'S Wheel-Chairs IOR Class I 1995-04-10
K950873 CARDON PHYSICAL THERAPY TABLES MODELS: R27622 Cardon Rehabilitation Products, Inc. INQ Class I 1995-04-10
K950904 ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) Orthofab, Inc. IOR Class I 1995-04-05
K945824 GALAXY MD SERIES THERAPYPOOLS Galaxy Aquatics, Inc. BXB Class I 1995-04-05
K950931 AVON MASSAGING HAIRBRUSH Siegel,Mandell & Davidson,P.C. ISA Class I 1995-04-05
K950903 ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR) Orthofab, Inc. IOR Class I 1995-04-05
K950400 HAND MASSAGE UNIT Ultrassage, Inc. IRO Class I 1995-03-30
K941675 TDP THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS C.M.D. Acupuncture Center & Herbs Store ILY Class II 1995-03-27
K950350 THEMALATOR. MODELS T-4-S, T-8-S, ETC. Whitehall/Div Columbus Mckennon Corp. IRQ Class I 1995-03-24
K950701 WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER Wahl Clipper Corp. IMA Class I 1995-03-24
K935982 SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS C.M.D. Acupuncture Center ILY Class II 1995-03-24
K945537 T-GUARD Med ET AL Development LQX Class I 1995-03-23
K951037 AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830 Akisu Machinery IOR Class I 1995-03-20
K951138 MODELS PHOENIX AND CONCEPT 45 MANUAL MECHANICAL WHEELCHAIRS Invacare Corp. IOR Class I 1995-03-20
K935868 DYNAPHOR(TM) TWO Maxxim Medical EGJ Class II 1995-03-15
K944329 BACK SPECIALIST Health Care Mfg., Inc. INQ Class I 1995-03-15
K950874 CARDON PHYSICAL THERAPY TABLES MODELS: R27610 Cardon Rehabilitation Products, Inc. INQ Class I 1995-03-14
K943430 CERVICAL FUNCTION INDICATOR Whiplash Analysis, Inc. LXJ Class II 1995-03-13
K931517 SAFE-STEP Lenjoy Engineering, Inc. IRN Class II 1995-03-10
K942694 STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 Biodex Medical Systems, Inc. KHX Class I 1995-03-10
K944819 KRDL 2000 Physicians Consulting, Inc. BXB Class I 1995-03-10
K950195 KARMA WHEELCHAIR Karman Healthcare, Inc. IOR Class I 1995-03-07
K950655 THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES Ultrassage, Inc. ISA Class I 1995-03-07
K945399 DELTA THERM COLD THERAPY SYSTEM Deltatherm ILO Class II 1995-03-07
K943197 KT1000/S KNEE LIGAMENT ARTHROMETER Medmetric Corp. LYH Class I 1995-03-02
K945221 SUTTER MODEL 6000 HAND CPM DEVICE Sutter Corp. BXB Class I 1995-02-27
K945729 DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE Hill-Rom, Inc. IOQ Class II 1995-02-27
K943385 CLINITRON ELEXIS Ssi Medical Services, Inc. INX Class II 1995-02-27
K941033 PHYSIO HAB Longo Industries ISD Class II 1995-02-27
K942229 MOTIVATOR FTR 2000 Hogan & Hartson IKK Class II 1995-02-27
K945667 MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION Micos Medical Systems KIC Class I 1995-02-21
K944585 SCANNING DIRECTOR Prentke Romich Co. IQA Class II 1995-02-21
K934754 THE HILL HI-LO TABLE Hill Laboratories Co. INQ Class I 1995-02-17
K942026 THE HILL ADJUSTABLE HA90E Hill Laboratories Co. INQ Class I 1995-02-17
K934151 MAGNATHERM MODEL 1000 SS Intl. Medical Electronics , Ltd. IMJ Class II 1995-02-17
K932810 THE HILL ADJUSTABLE AIR-FLEX MODEL Hill Laboratories Co. JFB Class II 1995-02-17
K945121 A3 ANKLE CPM UNIT Toronto Medical, Inc. BXB Class I 1995-02-17
K944884 DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B Kolvin Industries , Ltd. ISA Class I 1995-02-14
K950322 RELAXY-THE WONDER HAND Kinsei Shiatsu, Inc. ISA Class I 1995-02-14
K944730 MASSAGER North American Technical Services Corp. ISA Class I 1995-02-14
K950321 SHAPE UP MOMI ROLLER Kinsei Shiatsu, Inc. ISA Class I 1995-02-14
K944885 DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 Kolvin Industries , Ltd. ISA Class I 1995-02-14
K950320 RELAXY-WONDER KNOCK Kinsei Shiatsu, Inc. ISA Class I 1995-02-14
K941610 CLENSICAIR LOW AIRLOSS HYDROTHERAPY Support Systems Intl. IOQ Class II 1995-02-10
K950363 CARDONPHYSICAL THERAPY TABLE R27110 Cardon Rehabilitation Products, Inc. INQ Class I 1995-02-10
K950364 CARDON PHYSICAL THERAPY TABLES R27635 Cardon Rehabilitation Products, Inc. INQ Class I 1995-02-10
K950360 CARDON PHYSICAL THERAPY TABLE MODEL R28535 Cardon Rehabilitation Products, Inc. INQ Class I 1995-02-10
K950361 CARDON PHYSICAL THERAPY TABLE R28575 Cardon Rehabilitation Products, Inc. INQ Class I 1995-02-10
K950362 CARDON PHYSICAL THERAPY TABLE R27114 AND R27642 Cardon Rehabilitation Products, Inc. INQ Class I 1995-02-10
K944447 COOL/HEAT THERAPY APPLICATOR Medical Science Technology, Inc. ILO Class II 1995-02-09
K942882 TOTALLY COOL(TM) TC-2 Electro Science Technologies, Inc. ILO Class II 1995-02-09
K945067 EBICE Electro-Biology, Inc. ILO Class II 1995-02-09
K943844 TOTALLY COOL(TM) TC-1 Electro Science Technologies, Inc. ILO Class II 1995-02-09
K945603 CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) Headwaters, Inc. IRO Class I 1995-02-09
K946195 SUMMIT MECHANICAL WHEELCHAIR Summit Durable Medical Equipment, Inc. IOR Class I 1995-02-09
K942184 CLINITRON AT HOME AIR FLUIDED THERAPY Ssi Medical Services, Inc. INX Class II 1995-02-07
K944732 DEXTER ISOKINETIC Cedaron Medical, Inc. IKK Class II 1995-02-03
K940851 RED PACK MANLUAL POWER WHEELCHAIR CONVERSION KIT Redman, Inc. ITI Class II 1995-02-03
K940919 CHIEF SR Redman, Inc. IPL Class II 1995-02-03
K940852 CHIEF STANDUP WHEELCHAIR Redman, Inc. IPL Class II 1995-02-03
K940920 ROAD SAVAGE Redman, Inc. ITI Class II 1995-02-03
K935750 GERONIMO Redman, Inc. ITI Class II 1995-02-03
K935751 GERONIMO PR Redman, Inc. ITI Class II 1995-02-03
K946110 REGAIN STAND-UP WHEELCHAIR Regain, Inc. IPL Class II 1995-02-01
K946079 CAD ON WHEELS Rehab 'N Motion Technologies IOR Class I 1995-02-01
K944971 INCARE HOT/ICE COLD THERAPY COOLER Hollister, Inc. ILO Class II 1995-01-30
K940582 MASSAGING HELMET C.F. HANSEN DESIGN Philco Ushuaia IRO Class I 1995-01-30
K945954 MODELS 4100 AND 4300 MULTITHERAPY Spinalight, Inc. JFB Class II 1995-01-19
K936178 AGILANCE-GOLDEN SPOONS Oismuller & Partner Keg ISA Class I 1995-01-18
K935749 ROAD WARRIOR Redman, Inc. ITI Class II 1995-01-13
K940455 LATERAL FLEXION MACHINE Rehab, Inc. BXB Class I 1995-01-12
K935011 SWIMEX MULTIDEPTH POOL (MODEL 600T) Swimex Systems BXB Class I 1995-01-09
K945533 MECHANICAL WHEELCHAIR - SUPERNOVA Colours 'N Motion IOR Class I 1995-01-02
K945534 MECHANICAL WHEELCHAIR - BOING Colours 'N Motion IOR Class I 1995-01-02
K944277 DYNAMO Pride Health Care, Inc. INI Class II 1994-12-28
K940301 COMPEX 2 Biodex Medical Systems, Inc. IPF Class II 1994-12-28
K944308 JAMES LECKEY FREE STANDER James Leckey Design INW Class I 1994-12-22
K944307 JAMES LECKEY PRONE STANDER James Leckey Design INW Class I 1994-12-22
K945650 SPIFFY Thames Valley Children'S Centre INN Class I 1994-12-19
K935587 MULTILINK SHOULDER CPM UNIT Toronto Medical Corp. BXB Class I 1994-12-14
K944637 FAMILY FITNESS SHIATSU MASSAGER Conair Corp. ISA Class I 1994-12-13
K944970 SOLUTION Freedom Designs, Inc. IOR Class I 1994-12-13
K944134 K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 Myo-Tronics, Inc. KZM Class II 1994-12-09
K944024 STIMU-TAP Wahl Clipper Corp. ISA Class I 1994-12-08
K940065 SES100 Southwest Ergonomics ISD Class II 1994-12-06
K944423 POWER RECLINER Sunrise Medical, Inc. ITI Class II 1994-11-28
K943730 SQUEEZE PLAY Conair Corp. IRO Class I 1994-11-28
K943129 ECONOSTAND Sf Research Corp. IPL Class II 1994-11-17
K930820 AQUADYNE Aquatherapy Systems, Inc. ILJ Class II 1994-11-09
K930821 THERA-FIT Aquatherapy Systems, Inc. ILJ Class II 1994-11-09

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