meddevicedb.com FDA Device Reference

Review Panel

Physical Medicine FDA 510(k) Clearances & Devices

Cleared Devices
5,661
Product Codes (page)
34
Latest Decision
2014-02-18

Clearances · page 11 of 57

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K130385 COMPRESSIBLE LIMB SLEEVE SYSTEM Maxstar Industrial Co., Ltd. IRP Class II 2014-02-18
K132832 ACTIVAPATCH ET IONTOPHORESIS PATCH Activatek, Inc. EGJ Class II 2014-02-13
K132257 MANUAL WHEELCHAIR Zhejiang Jiafeng Electrical & Mechanial Co., Ltd. IOR Class I 2014-02-13
K130723 FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL Famidoc Technology Co., Ltd. NGX Class II 2014-02-07
K130864 C-MAX+ (PLUS) Aat Alber Antriebstechnik GmbH ILK Class II 2014-02-06
K130249 INTEGRITY SPINAL CARE SYSTEM 3.0 Integrity Life Sciences ITH Class II 2014-02-06
K133855 BREEZY ELEGANCE Sunrise Medical (Us), LLC IOR Class I 2014-01-31
K131309 SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ Ibramed Equipamentos Medicos IMI Class II 2014-01-27
K131113 BIOPHOTAS CELLUMA Biophotas, Inc. ILY Class II 2014-01-15
K130168 CL10009 IR LASER Curae'Lase, Inc. ILY Class II 2014-01-10
K130888 SONOPULSE/ SONOPULSE III Ibramed- Industria Brazileria DE Equipamentos Medi IMI Class II 2014-01-09
K131259 LASER-STIM Shenzhen Dongdixin Technology Co., Ltd. ILY Class II 2013-12-27
K132646 SUNETICS CLINICAL BIO-STIMULATION LASER Sunetics International Marketing Group, LLC OAP Class II 2013-12-20
K130052 TONE-A-MATIC Tone-A-Matic International, Inc. IPF Class II 2013-12-20
K130691 ELECTROTHERAPY DEVICE (COMBO UNIT) Guangzhou Finecure Medical Equipment Co.,Ltd IPF Class II 2013-12-20
DEN110011 SYMPHONY DEVICE Sensory Medical, Inc. OVP Class II 2013-12-18
DEN110009 RESTLESS LEG DEVICE Mary M. Sorg (An Individual) Dba PJ Sleeper'S OTX Class I 2013-12-18
K131979 PROVANT THERAPY SYSTEM Regenesis Biomedical, Inc. ILX Class II 2013-12-13
K122393 TG-BODY MI&BODY S-TRAINER Miga Medical Co., Ltd. NGX Class II 2013-12-10
K130788 CAPELLA Future Mobility Healthcare, Inc. IOR Class I 2013-12-05
K123474 AVANT LASER Avant Wellness Systems, LLC ILY Class II 2013-12-03
K131629 NEURODYN MULTIWAVE, AUSSIE SPORT Ibramed Equipamentos Medicos IPF Class II 2013-11-26
K131302 SOLAX Dongguan Prestige Sporting Goods Co., Ltd. INI Class II 2013-11-26
K130848 SHANGHAI PHOENIX MECHANICAL WHEELCHAIR Shanghai Phoenix Medical Equipment Co., Ltd. IOR Class I 2013-11-12
K130978 ZTX ULTRASONIC DIATHERMY DEVICE Zetroz, Inc. PFW Class II 2013-11-06
K131222 AMPCARE ESP THERAPY SYSTEM Ampcare, LLC IPF Class II 2013-10-31
K131336 TX WHEELCHAIR CHASSIS Jcm Seating Solutions, Ltd. IOR Class I 2013-10-28
K130866 BIOLIGHT BIODYNAM Biolight AB ILY Class II 2013-10-25
K130644 PEDIATRIC FOLDING WHEELCHAIR Columbia Medical Mfg, LLC LBE Class I 2013-10-16
K131797 3B LASER NEEDLE Livetec GmbH ILY Class II 2013-10-10
K130940 KYMCO EQ20C SCOOTER Kwang Yang Motor Co., Ltd. INI Class II 2013-10-07
K131529 SHENGGUANG MANUAL WHEELCHAIR Pingdingshan Shenxing Healthcare Technology Co., L IOR Class I 2013-09-24
K130996 ERCHONIA EMERGE Erchonia Medical, Inc. NHN Class II 2013-09-16
K123902 PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) Oktx, LLC IKN Class II 2013-09-13
K132137 MULTISTIM Metron Medical Australia, Pty, Ltd. IPF Class II 2013-09-12
K124010 ACCUSONIC ADVANTAGE Metron Medical Australia, Pty, Ltd. IMI Class II 2013-08-23
K123975 QUICKIE & ZIPPIE SERIES Sunrise Medical IOR Class I 2013-08-16
K130074 GYMFORM ABS-A-ROUND Well Brain International , Ltd. NGX Class II 2013-08-15
K123834 EASYSTAND BANTAM MEDIUM Altimate Medical, Inc. INO Class II 2013-08-13
K122562 E-TENG MODEL EOR 1 E-Teng Technology, Inc. IPL Class II 2013-08-09
K123076 PROFTHAND MECHANICAL WHEELCHAIR Harmony Hill International IOR Class I 2013-08-09
K123399 MYOVISION 3.0 WIREFREE SYSTEM Precision Biometrics, Inc. IKN Class II 2013-08-01
K130158 M-SCAN Bio-Research Associates, Inc. KZM Class II 2013-07-25
K123075 BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E Well-Life Healthcare Limited NGX Class II 2013-07-11
K130424 STIMEL-03 Stimel, Ltd. IPF Class II 2013-07-11
K123177 STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM Laserstim, Inc. ILY Class II 2013-07-03
K123354 REVITIVE IX Actegy , Ltd. IPF Class II 2013-06-28
K121920 LASERBRUSH Sunetics International Marketing Group, LLC OAP Class II 2013-06-27
K123158 ION MAGNUM GENIUS Ion Genius, Inc. NGX Class II 2013-06-21
K122950 LASER HELMET Theradome, Inc. OAP Class II 2013-06-14
K131291 TORC BODY Johari Digital Healthcare , Ltd. NGX Class II 2013-06-14
K122473 TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 Hill-Rom IOQ Class II 2013-06-03
K123746 AMES THERAPY DEVICE Ames Technology, Inc. IKK Class II 2013-05-24
K123769 ZX-I POWER ADD ON Spinergy, Inc. ITI Class II 2013-05-10
K121719 SM TENS & PMS Hong Qiangxing (Shenzhen) Electronics Limited NGX Class II 2013-05-10
K122741 HOVEROUND TEKNIQUE Hoveround Corp. ITI Class II 2013-05-07
K122707 HOVERROUND TEKNIQUE Hoveround Corp. ITI Class II 2013-05-07
K124016 EMPI PHOENIX Djo, LLC IPF Class II 2013-05-06
K121702 ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE Orthocor Medical ILX Class II 2013-05-06
K123971 CYNOSURE 1064NM DIODE LASER Cynosure, Inc. ILY Class II 2013-05-02
K121401 TENDER TOUCH Sometech Corporation ILY Class II 2013-05-01
K130741 ERCHONIA PL5000 Erchonia Medical, Inc. NHN Class II 2013-04-23
K123290 M300 & M400 Permobil AB ITI Class II 2013-04-17
K122112 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM Bio Compression Systems, Inc. IRP Class II 2013-04-09
K123829 PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK Portable Therapeutix, LLC IRP Class II 2013-04-03
K123642 MUSCLE STIMULATION SYSTEM Niveus Medical, Inc. IPF Class II 2013-03-29
K122206 GARAVENTA X3 INCLINED PLATFORM LIFT Garaventa (Canada) Ltd [Dba Garaventa Lift] PCE Class II 2013-03-21
K113164 DISCOVERY TMAX MANUAL WHEELCHAIR Otto Bock Healthcare LP IOR Class I 2013-03-11
K120922 GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT Selectivemed Components, Inc. IPF Class II 2013-02-07
K122125 ASA LASER SH1 El.En Electronic Engineering Spa ILY Class II 2013-01-25
K122357 MERITS MODEL P322FWD POWERED WHEELCHAIR Merits Health Products Co., Ltd. ITI Class II 2013-01-09
K122237 BIOPHOTAS LIFELIGHT Biophotas, Inc. ILY Class II 2013-01-03
K121661 EZ-ASSIST-FILL Assist Fill, LLC PCM Class I 2012-12-27
K122749 PRESTIGE-MOBIE Prestige Sporting Goods Co. , Ltd. INI Class II 2012-12-27
K113010 FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR Famidoc Technology Co., Ltd. IPF Class II 2012-12-21
K120391 MR4500 WHEELCHAIR Wardray Premise, Ltd. IOR Class I 2012-12-21
K122414 AB COMMAND DUAL CHANNEL FITNESS BELT Leto Enterprises Incorporation NGX Class II 2012-12-21
K120628 HELIO Motion Composites IOR Class I 2012-12-19
K122248 IGROW II HAIR GROWTH SYSTEM Apira Science, Inc. OAP Class II 2012-12-05
K121363 DIOWAVE LOW LEVEL COLD LASER SYSTEM Technological Medical Advancments, Inc. (Tma) ILY Class II 2012-11-23
K120217 SONICSTIMU COMBO THERAPEUTIC DEVICE Shenzhen Dongdixin Technology Co., Ltd. IMG Class II 2012-11-21
K122154 POWERPLAY MUSCLE MASSAGER Fig, LLC IRP Class II 2012-11-21
DEN100023 AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 National Center For Pelvic Pain Research Devices, OSD Class II 2012-11-20
K121560 LEVANT, HOMEGLIDE Thyssenkrupp Accessibility B.V. ILK Class II 2012-11-01
K112121 ERGOSELECT/GE Ergoline GmbH ISD Class II 2012-10-31
K121561 FLOW2, SWING Thyssenkrupp Accessibility B.V. ILK Class II 2012-10-26
K111588 LEGACY-500 Mt Tables, LLC JFB Class II 2012-10-26
K120093 BTL ELITE BTL Industries, Inc. IMJ Class II 2012-10-05
K120501 CHAMP CHAMP TRANSIT Convaid Products, Inc. IOR Class I 2012-09-20
K120405 WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR Walk on Wheels Australia Pty, Ltd. ITI Class II 2012-09-19
K121059 SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM Zimmer Medizinsystems GmbH IMG Class II 2012-08-07
K121338 ZEOBI Ivivi Health Science, LLC ILX Class II 2012-07-27
K110558 CS1000 LIGHT THERAPY DEVICE Genesis Health Light Corporation ILY Class II 2012-07-12
K111781 GYMFORM DUAL FLEX BELT MODEL WB-162 Well Brain International , Ltd. NGX Class II 2012-07-11
K120582 HEATLUX Home Skinovations , Ltd. ILY Class II 2012-07-06
K120302 MECHANICAL WHEELCHAIR Novaf Andalucia 2007, SL IQC Class II 2012-07-06
K113621 SMARTDRIVE WHEELCHAIR POWER-ASSIST Max Mobility, LLC ITI Class II 2012-07-06
K113017 SYS*STIM 240 Mettler Electronics Corp. IPF Class II 2012-06-26
K120342 EMG RECORDING ELECTRODE ASSEMBLY Rhythmlink International, LLC IKT Class II 2012-06-22
K120783 ABLE-X Im-Able, Ltd. ION Class I 2012-06-20

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