FDA 510(k) Applications for Medical Device:
Blood Pressure Cuff
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K063863 | ADVANTAGE MEDICAL CABLES, INC. |
10630 WILES RD. | CORAL SPRINGS | FL | 33076 |
| K962655 | AMERICAN DIAGNOSTIC CORP. |
93 OTIS ST. | WEST BABYLON | NY | 11704 |
| K133117 | ANDON HEALTH CO., LTD |
No. 3 Jin Ping Street,Ya An Road, | TIANJIN | 300190 | |
| K102825 | APK TECHNOLOGY CO., LTD |
P.O. BOX 237-023 | SHANGHAI | 518126 | |
| K023356 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. | REHOVOT | 76100 | |
| K082542 | CARDICARE COMPANY, LTD. |
9 YAN AN ROAD, WU SHAN PLAZA | HANGZHOU, ZHEJIANG | 310002 | |
| K222652 | Cardicare Company, Ltd. |
9 Yan An Road, Wu Shan Plaza Town, Unit 7003 | Hangzhou City | 310002 | |
| K090014 | CAREMATE MEDICAL DEVICE CO., LTD |
SUITE 8D, NO. 19, LANE 999 | SHANGHAI | 200030 | |
| K102792 | CAREMATE MEDICAL DEVICE CO., LTD |
P.O. BOX 237-023 | SHANGHAI | 200237 | |
| K000512 | CAS MEDICAL SYSTEMS, INC. |
44 EAST INDUSTRIAL RD. | BRANFORD | CT | 06405 |
| K031416 | CLEAR MEDICAL, INC. |
1776 136TH PL. NE | BELLEVUE | WA | 98005 |
| K972899 | CYPRESS MEDICAL PRODUCTS, LTD. |
1202 SOUTH ROUTE 31 | MCHENRY | IL | 60050 |
| K041689 | D. E. HOKANSON, INC. |
12840 N.E. 21ST PL. | BELLEVUE | WA | 98005-1910 |
| K991525 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K090664 | DEVON MEDICAL INC. |
1100 1ST AVENUE | KING OF PRUSSIA | PA | 19406 |
| K191209 | Dongguan Mars Medical Products Co., Ltd |
381, Manfeng West Road, Manfeng Group | Dani Village, Shatian Town, Dongguan Cit | 523993 | |
| K092999 | DRAEGER MEDICAL AG & CO. KG |
3135 Quarry Road | Telford | PA | 18969 |
| K103637 | ERKA KALLMEYER MEDIZINTECHNIK GMBH |
IM FARCHET 15 | BAD TOELZ, BAVARIA | 83646 | |
| K031195 | ETHOX CORP. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K040286 | ETHOX CORP. |
251 SENECA ST. | BUFFALO | NY | 14204 |
| K061962 | ETHOX INTERNATIONAL |
251 SENECA ST. | BUFFALO | NY | 14204 |
| K022482 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4502 WOODLAND CORPORATE BLVD. | TAMPA | FL | 33614 |
| K230145 | GE Medical Systems Information Technologies, Inc. |
9900 W Innovation Dr. | Wauwatosa | WI | 53226 |
| K123996 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K120125 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
8200 WEST TOWER AVE. | MILWAUKEE | WI | 53223 |
| K012553 | GLOBALSHOP, INC. |
1156 EAST RIDGEWOOD AVE. | RIDGEWOOD | NJ | 07450 |
| K010686 | GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. |
1156 E. RIDGEWOOD AVE. | RIDGEWOOD | NJ | 07451 |
| K043444 | GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. |
1800 CENTURY PARK EAST | LOS ANGELES | CA | 90067 |
| K122259 | HANGZHOU RELI-ON CO., LTD |
77325 JOYCE WAY | ECHO | OR | 97826 |
| K101892 | HEINE OPTOTECHNIK GMBH & CO. KG. |
BEIM STROHHAUSE 27 | HAMBURG | 20097 | |
| K092245 | HONSUN (NANTONG) CO., LTD |
ADD: NO8 TONGXING ROAD | JIANGSU | ||
| K192500 | Honsun(Nantong)Co.,Ltd |
No.8, Tongxing Road, Nantong Economic & Technology | Nantong | 226009 | |
| K152006 | ICU MEDICAL INC. |
951 CALLE AMANECER | SAN CLEMENTE | CA | 92673 |
| K991545 | INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI |
11641 RED HIBISCUS DR. | BONITA SPRINGS | FL | 34135 |
| K151246 | Jiaxing Zhongfa Medical Products Co., Ltd. |
No.38 Building 1, Zhong Fa Group | Jiaxing | 314008 | |
| K203652 | JKH USA, LLC |
20505 Valley Blvd. Suite 108 | Walnut | CA | 91789 |
| K974080 | JOHNSON & JOHNSON MEDICAL, INC. |
4110 GEORGE RD. | TAMPA | FL | 33634 |
| K143332 | KOVEN TECHNOLOGY, INC. |
12125 WOODCREST EXECUTIVE DR. | ST. LOUIS | MO | 63141 |
| K130942 | LEGACY MEDICAL, INC. |
9039 Horizon Dr | Shakopee | MN | 55379 |
| K193259 | Little Doctor Electronic (Nantong)Co.,Ltd |
No.14, Zhenxingxilu Road, Chongchuan Area | Nantong | 226000 | |
| K032568 | MED TEXTILE, LLC |
14300 WOOD DUCK LANE | COLONIAL HEIGHTS | VA | 23834 |
| K161035 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K071244 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K963987 | N.A. BRAGGS MEDICAL, INC. |
8255 BRACKETT LN. | SEMMES | AL | 36575 |
| K012194 | NIHON SEIMITSU SOKKI CO., LTD. |
2508-13 NAKAGO | GUNMA-KEN | 377-0293 | |
| K173044 | Ningbo Albert Novosino Co.,Ltd. |
No.1 Xinheng 3 Road Cicheng Town | Ningbo | 315036 | |
| K153251 | NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD. |
24/F, 238 ZHONGSHAN EAST ROAD | NINGBO | 315010 | |
| K173197 | Orantech Inc. |
Zone#A, 4F, 1st Bld, 7th Industrial Zone | Guangming New District, Shenzhen | 518106 | |
| K002360 | PARTS PORT, LTD. |
1801 WALTHALL CREEK DR. | COLONIAL HEIGHTS | VA | 23834 |
| K152363 | PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD | ANDOVER | MA | 03104-1099 |
| K141998 | PINGHU SAMA MEDICAL PACKING CO., LTD. |
853 DORCHESTER LN, UNIT-B | NEW MILFORD | NJ | 07646 |
| K150227 | PINHU SAMA MEDICAL PACKING CO., LTD. |
1 QUNFENG ROAD, SOUTH OF LINDAI | PINGHU | 214202 | |
| K964648 | PROTECT ALL, INC. |
228 GOLF COURSE RD. | PIEDMONT | SC | 29673 |
| K012444 | PT. SUGIH INSTRUMENDO ABADI |
933A MOTOR PKWY. | HAUPPAUGE | NY | 11788 |
| K053006 | ROSSMAX INTERNATIONL LTD. |
12F, NO. 189, KANG CHIEN RD. | TAIPEI | 114 | |
| K972301 | RUDOLF RIESTER GMBH & CO. KG |
BRUCKSTRASSE 31 | JUNGINGEN | D-72417 | |
| K002955 | RUDOLF RIESTER GMBH & CO. KG |
BRUCKSTRASSE 31 | JUNGINGEN | D-72417 | |
| K972379 | RUDOLF RIESTER GMBH & CO. KG |
BRUCKSTRASSE 31 | JUNGINGEN | D-72417 | |
| K972377 | RUDOLF RIESTER GMBH & CO. KG |
BRUCKSTRASSE 31 | JUNGINGEN | D-72417 | |
| K002954 | RUDOLF RIESTER GMBH & CO. KG |
BRUCKSTRASSE 31 | JUNGINGEN | D-72417 | |
| K972378 | RUDOLF RIESTER GMBH & CO. KG |
BRUCKSTRASSE 31 | JUNGINGEN | D-72417 | |
| K211084 | Shanghai Caremate Medical Device Co. Ltd |
Building 4, No. 281, Hong An Road, Jinshan District, | Shanghai | 201503 | |
| K140874 | SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY |
144 RESEARCG DRIVE | HAMPTON | VA | 23666 |
| K180335 | Shanghai Hulu Devices Co., Ltd |
No. 509 Caobao Road, | Shanghai | ||
| K051021 | SHANGHAI LORD INTERNATIONAL TRADE CO., LTD. |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K182433 | Shenzhen Caremed Medical Technology Co., Ltd. |
East Side, 3/F, C Building, Kelunte Low-Carbon Industries | Dalang Office, Longhua District, Shenzhe | 518109 | |
| K193629 | Shenzhen Changke Connect Electronics Co., Ltd. |
A2-4th floor of Xiang dali Technology Park | Longgang District, Shenzhen | 518000 | |
| K191253 | Shenzhen Changke Connect Electronics Co., Ltd. |
A2-4th floor of Xiang dali Technology Park | Longgang District, Shenzhen | ||
| K211747 | Shenzhen Coreray Technology Co., Ltd. |
Floor 5, Building 10, Huangbeiling Jingxuan Industrial Park | Shenzhen | 518109 | |
| K173869 | Shenzhen Med-link Electronics Tech Co., Ltd |
4th Floor, Building A, Ying Tailong Ind Park | Shenzhen | 518109 | |
| K160530 | SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
4TH FL, BLDG A, YINGTAILONG INDUSTRIAL PRK, | Shenzhen | 518109 | |
| K151810 | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
2/F, M-7 SINOSTEEL BUILDING, MAQUELING ESTATE | NANSHAN DISTRICT, SHENZHEN | 518057 | |
| K231961 | Shenzhen SINO-K Medical Technology Co.,Ltd |
Room401,Bldg2,Veteran Ind.city,Gonglc Community | Shenzhen | 518115 | |
| K152465 | Shenzhen Vistar Medical Supplies Co., Ltd. |
808, Hanhaida Bldg., No. 7 Songgang Blvd. | Shenzhen | 518105 | |
| K152468 | Shenzhen Vistar Medical Supplies Co., Ltd. |
808, Hanhaida Bldg., No. 7 Songgang Blvd. | Shenzhen | 518105 | |
| K101972 | SOLARIS MEDICAL TECHNOLOGY, INC. |
400 OYSTER POINT BLVD. | SOUTH SAN FRANCISCO | CA | 94080 |
| K152801 | STATCORP MEDICAL |
14476 Duval Place West | JACKSONVILLE | FL | 32218 |
| K954282 | STATCORP, INC. |
1200 COLUMBIA AVE. | FRANKLIN | TN | 37065 |
| K051904 | SUNTECH MEDICAL, INC. |
507 AIRPORT BOULEVARD | MORRISVILLE | NC | 27560 |
| K080854 | SUNTECH MEDICAL, INC. |
507 AIRPORT BOULEVARD | MORRISVILLE | NC | 27560 |
| K141392 | SUZHOU JJ METER CO., LTD. |
R1508, EAST BLDG, YIHAI PLAZA | SHENZHEN, GUANGDONG | 518054 | |
| K143728 | SUZHOU MINHUA MEDICAL APPARATUS |
You Yi Industrial Park | Songlin Town | 215222 | |
| K171889 | Suzhou Minhua Medical Apparatus Supplies Co., LTD |
You Yi Industrial Park, Songlin Town, Wujiang | Suzhou | 215222 | |
| K092604 | TRIMLINE MEDICAL PRODUCTS CORP. |
34 COLUMBIA AVE. | BRANCHBURG | NJ | 08876 |
| K080189 | TRIMLINE MEDICAL PRODUCTS CORP. |
34 COLUMBIA AVE. | BRANCHBURG | NJ | 08876 |
| K062238 | TYTAN MEDICAL CORP. |
NO 58, FU-CHIUN ST. | HSIN-CHU CITY | 30067 | |
| K112544 | UNIMED MEDICAL SUPPLIES INC. |
NO.37, YANSHAN ROAD, SHEKOU | SHENZHEN, GUANGDONG | 518067 | |
| K120364 | UNIMED MEDICAL SUPPLIES INC. |
NO.37, YANSHAN ROAD, SHEKOU | SHENZHEN, GUANGDONG | 518067 | |
| K994044 | VITAL SIGNS, INC. |
20 CAMPUS RD. | TOTOWA | NJ | 07512 |
| K990412 | VITAL SIGNS, INC. |
20 CAMPUS RD. | TOTOWA | NJ | 07512 |
| K202543 | Volcano Corporation |
3721 Valley Centre Drive, Ste 500 | San Diego | CA | 92130 |
| K003415 | WANG & LI, INC. |
2026 COYLE ST. | BROOKLYN | NY | 11229 |
| K122058 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K012455 | WELCH ALLYN, INC. |
95 OLD SHOALS RD. | ARDEN | NC | 28704 |
| K070060 | WELCH ALLYN, INC. |
4341 STATE STREET ROAD | SKANEATELES FALLS | NY | 13153-0220 |
| K043286 | WENZHOU BOKANG INSTRUMENT CO.,LTD |
4413 GLENDALE ST. | METAIRIE | LA | 70006 |
| K173246 | Wenzhou Bokang Instruments Co., Ltd |
No. 1500 Haining Road, Haibin Longwan | Wenzhou | 325024 | |
| K230859 | Wenzhou Kangshun Medical Devices Co.,Ltd |
No. 706 Yanyun Road,Lingkun Street,Oujiangkou Industrial | Wenzhou City | 325011 | |
| K081951 | WENZHOU KINDCARE IMPORT & EXPORT CO., LTD |
340 SHADY GROVE ROAD | FLINTVILLE | TN | 37335 |
| K060871 | WENZHOU LONGWAN MEDICAL INSTRUMENT COMPANY |
340 SHADY GROVE ROAD | FLINTVILLE | TN | 37335 |
| K190902 | Wenzhou Renhua Instruments Co., Ltd |
#.1-1704 Wanda Business Building Yongding Road, | Wenzhou | 325024 | |
| K212416 | Wenzhou Xikang Medical Instruments Co., Ltd |
No.1478 Haining Road, Haibin Street, Longwan District | Wenzhou | 325024 | |
| K222420 | Wenzhou Xikang Medical Instruments Co., Ltd. |
No. 1478 Haining Road, Haibin Street, Longwan District | Wenzhou | 325024 | |
| K203620 | Wuxi Exanovo Medical Instrument Co., Ltd. |
No. 42, Xixin Road, Zhangjing, Xibei Town | Wuxi | 214194 | |
| K102823 | WUXI MEDICAL INSTRUMENT FACTORY |
P.O. BOX 237-023 | SHANGHAI | 200237 | |
| K151290 | XUZHOU MAICUFF TECHNOLOGY CO.,LTD. |
8#-2-1106, JINXIUJIAYUAN, JIANGUO WEST ROAD | XUZHOU | 221006 | |
| K051539 | YA HORNG ELECTRONIC CO., LTD. |
NO. 58, FU-CHIUN ST. | HSIN-CHU CITY | 30067 | |
| K080366 | ZEFON INTL. |
5350 S.W. FIRST LN. | OCALA | FL | 34474 |
| K082630 | ZEFON INTL. |
5350 S.W. FIRST LN. | OCALA | FL | 34474 |
| K221857 | Zhejiang LuDe Technology Development Co., Ltd. |
NO. 298 Jichang North Road, Longwan District | Wenzhou | 325024 |
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