FDA 510(k) Applications for Medical Device:
Device, Iontophoresis, Other Uses

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K061849 AA ADVANCED TECHNOLOGY INC. 1676 VILLAGE GREEN
CROFTON MD 21114
K073276 ACCLARENT, INC. 1525-B O'BRIEN DR.
MENLO PARK CA 94025
K110636 ACCLARENT, INC. 1525-B O'BRIEN DR.
MENLO PARK CA 94025
K150453 ACCLARENT, INC. 1525-B O'BRIEN DR.
MENLO PARK CA 94025
K061522 ACTIVA TEK INC 340 BROADWAY CENTRE
SALT LAKE CITY UT 84111
K091326 ACTIVATEK INC. 2734 S. 3600 WEST
WEST VALLEY UT 84120
K132832 ACTIVATEK INC. 2734 S. 3600 WEST
WEST VALLEY CITY UT 84119
K080580 AXELGAARD MFG. CO., LTD. 520 INDUSTRIAL WAY
FALLBROOK CA 92028-2244
K992708 BIRCH POINT MEDICAL, INC. 2660 PATTON RD.
ROSEVILLE MN 55113
K192749 Dermadry Laboratories inc. 9223 Langelier Blvd
Montreal H1P 3K9
K043047 DYNATRONICS CORP. 7030 PARK CENTRE DR.
SALT LAKE CITY UT 84121
K060814 DYNATRONICS CORP. 7030 PARK CENTRE DR.
SALT LAKE CITY UT 84121
K031769 EEMSO, INC. 1900 K STREET, NW
WASHINGTON DC 20006
K983484 EMPI 599 CARDIGAN RD.
ST. PAUL MN 55126
K970491 EMPI 599 CARDIGAN RD.
ST. PAUL MN 55126
K991991 EMPI 599 CARDIGAN RD.
ST. PAUL MN 55126
K070427 EMPI 599 CARDIGAN RD.
ST. PAUL MN 55126
K030395 EMPI 1800 MASSACHUSETTS AVE NW
WASHINGTON DC 20036-1221
K072946 EMPI 599 CARDIGAN RD.
ST. PAUL MN 55126
K062792 ERCHONIA MEDICAL, INC. 13 RED FOX LANE
LITTLETON CO 80127
K133033 HIDREX GMBH 2611 SHARK CIRCLE
TEXAS CITY TX 77591
K241267 Hidroxa Medical AB Bjorndammsterrassen 114
Partille 43342
K170835 Hightech Development Janovskeho 979/11
Prague 170 00
K063465 IOMED, INC. 2441 SOUTH 3850 WEST, SUITE A
SALT LAKE CITY UT 84120-9941
K060236 IOMED, INC. 2441 SOUTH 3850 WEST, SUITE A
SALT LAKE CITY UT 84120-9941
K982668 IOMED, INC. 3385 WEST 1820 SOUTH
SALT LAKE CITY UT 84104
K042590 MATTIOLI ENGINEERING CORP. 11800 BALTIMORE AVENUE
BELTSVILLE MD 20705
K032968 MATTIOLI ENGINEERING CORP. 11800 BALTIMORE AVENUE
BELTSVILLE MD 20705
K041101 MEDICAL ADHESIVEONLINE, LLC. 10809 GARDEN MIST
LAS VEGAS NV 89135
K083016 MICROLAB AMERICAS INC 1468 HARWELL AVE
CROFTON MD 2114
K040495 NAIMCO, INC. 4120 SOUTH CREEK ROAD
CHATTANOOGA TN 37406
K052019 NORTH COAST MEDICAL, INC. 18305 SUTTER BLVD.
MORGAN HILL CA 95037-2845
K060579 PEPIN MFG., INC. 800 LEVANGER LANE
STOUGHTON WI 53589
K022950 PHYSION, INC. 51 JOHN F. KENNEDY PKWY.
SHORT HILLS NJ 07078-5006
K964208 R. A. FISCHER CO. CORP. 517 COMMERCIAL ST.
GLENDALE CA 91203
K191436 Saalmann medical GmbH & Co. KG Sudbahnstrabe 34
Bad Oeynhausen 32547
K993081 SELECTIVE MED COMPONENTS, INC. 6 S. MECHANIC ST.
MOUNT VERNON OH 43050
K020476 SELECTIVE MED COMPONENTS, INC. 6 MECHANIC ST.
MOUNT VERNON OH 43050
K031053 SELECTIVE MED COMPONENTS, INC. 201 WEST HIGH ST.
MOUNT VERNON OH 43050
K170291 SOTERIX MEDICAL,INC. 237 W 35 ST, 1401
NEW YORK NY 10001
K242041 Taiwan Medical Electronics Co., Ltd. Rm. 5, 3F., No. 49, Sec. 3, Zhongshan N. Rd.,
Taipei City 104029
K232020 TOP-RANK Health Care Co., Ltd. Mcshan Village, Dongguan Street, Shangyu District,
Shaoxing 312352
K000574 WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET
STILLWATER MN 55082




Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact