|
Device |
stimulator, muscle, powered |
Product Code | IPF |
Regulation Number |
890.5850
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACTEGY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMPCARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARP MANUFACTURING, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASTEK TECHNOLOGY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO PROTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO-MEDICAL RESEARCH, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BTL INDUSTRIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BTL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHATTANOOGA GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CYMEDICA ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
DIGITIMER LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DJO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
EGZOTECH SP. Z O. O. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EL. EN. ELECTRONIC ENGINEERING SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EL.EN. S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELECTRONIC WAVEFORM LABORATORY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELITE MEDICAL SUPPLY OF NEW YORK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMPI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMSI |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EMSI, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ESWALLOW USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FAMIDOC TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIRSTKIND LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
FIRSTKIND LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOWAID MEDICAL TECHNOLOGIES, CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOTONA D.O.O. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
G.TEC MEDICAL ENGINEERING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HILLTEK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IBRAMED EQUIPAMENTOS MEDICOS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INMODE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDLANDER MEDICAL TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
METRON MEDICAL AUSTRALIA PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
METTLER ELECTRONICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
METTLER ELECTRONICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MYOWORX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NCS LAB SRL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEUROTRIGGER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIVEUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OTTO BOCK, AUSTRIA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAJUNK GMBH MEDIZINTECHNOLOGIE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHYSIOMED ELEKTROMEDIZIN AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REHABTRONICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESTORATIVE THERAPIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SELECTIVEMED COMPONENTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHEAR STRESS THERAPEUTICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN KONMED TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ROUNDWHALE TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN XFT MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMARTMISSIMO TECHNOLOGIES PTE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STIMEL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STIMMED, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STORZ MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SWIMS AMERICA CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THERASIGMA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THOUGHT TECHNOLOGY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIMEWAVER PRODUCTION GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TONE-A-MATIC INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UMEHEAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALMED, SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISION QUEST INDUSTRIES INC./DBA VQ ORTHOCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISION QUEST INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER MEDIZINSYSTEME GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZYNEX MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZYNEX MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|