FDA 510(k) Applications for Medical Device:
Analyzer, Body Composition
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K073227 | AIIA COMMUNICATION INC. |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K051589 | AIIA COMMUNICATION INC. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K091369 | AKERN USA, LLC |
5401 S. COTTONWOOD COURT | GREENWOOD VILLAGE | CO | 80121 |
| K120896 | ANDON HEALTH CO., LTD |
No. 3 Jin Ping Street,Ya An Road, | TIANJIN | 300190 | |
| K060552 | ATHLETIC IQ, INC. |
5 WHITCOMB AVENUE | AYER | MA | 01432 |
| K020738 | AVITA CORPORATION |
3892 SOUTH AMERICA WEST TRAIL, | FLAGGSTAFF | AZ | 86001 |
| K060538 | BEAVERITE INTERNATIONAL LIMITED |
5600 WISCONSIN AVE. | CHEVY CHASE | MD | 20815 |
| K051675 | BIODYNAMICS CORP. |
4554 9TH AVENUE NE, #100 | SEATTLE | WA | 98105 |
| K023478 | BIOSPACE CO.,LTD |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K141483 | BIOSPACE CORPORATION LIMITED |
8870 RAVELLO CT | NAPLES | FL | 34114 |
| K062603 | BIOSPACE CORPORATION LIMITED |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K052646 | BIOSPACE CORPORATION LIMITED |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K110689 | BIOSPACE CORPORATION LIMITED |
8870 RAVELLO CT | NAPLES | FL | 34114 |
| K130777 | BIOSPACE CORPORATION LIMITED |
8870 RAVELLO CT | NAPLES | FL | 34114 |
| K123228 | BIOSPACE CORPORATION LIMITED |
8870 RAVELLO CT | NAPLES | FL | 34114 |
| K042528 | BIOSPACE CORPORATION LIMITED |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K092786 | BIOSPACE CORPORATION LIMITED |
8726 FERRARA CT. | NAPLES | FL | 34114 |
| K002835 | BODYSTAT LTD. |
PO BOX 50 | BRITISH ISLES | IM99 1DQ | |
| K971554 | BODYSTAT LTD. |
PO BOX 50 | BRITISH ISLES | IM99 1DQ | |
| K082253 | BODYSTAT LTD. |
PO BOX 50 | BRITISH ISLES | IM99 1DQ | |
| K994242 | BODYSTAT LTD. |
PO BOX 50 | BRITISH ISLES | IM99 1DQ | |
| K980971 | BODYSTAT LTD. |
PO BOX 50 | BRITISH ISLES | IM99 1DQ | |
| K082254 | BODYSTAT LTD. |
PO BOX 50 | BRITISH ISLES | IM99 1DQ | |
| K082255 | BODYSTAT LTD. |
PO BOX 50 | BRITISH ISLES | IM99 1DQ | |
| K030349 | BONSO ELECTRONICS INTERNATIONAL INC. |
719 A STREET, NE | WASHINGTON | DC | 20002 |
| K073334 | CHRISTINE VALMY INC |
285, CHANGE BRIDGE ROAD | PINE BROOK | NJ | 07058 |
| K023817 | CLIO DESIGNS, INC. |
ONE GROVE ST. | WATERTOWN | MA | 02472 |
| K140594 | CONMO ELECTRONIC COMPANY LIMITED |
12226 WASHINGTON LANE | PARKER | AZ | 85344 |
| K060642 | DUTECK INDUSTRIAL CO., LTD. |
3F-2, NO. 26, 513 LANE | TAIPEI | 114 | |
| K133872 | FITBIT, INC. |
2995 STEVEN MARTIN DRIVE | FAIRFAX | VA | 22031 |
| K083838 | FOOK TIN TECHNOLOGIES LIMITED |
4/F., EASTERN CENTRE | QUARRY BAY | ||
| K963271 | FUTREX, INC. |
6 MONTGOMERY VILLAGE AVE., | GAITHERSBURG | MD | 20879 |
| K130311 | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
NO.1 FANGHUA STREET, HI-TECH DISTRICT | CHENGDU | 610041 | |
| K131394 | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD |
NO.1 FANGHUA STREET, HI-TECH DISTRICT | CHENGDU, SICHUAN | 610041 | |
| K043414 | HEALTH & LIFE CO., LTD. |
3892 SOUTH AMERICA WEST TRAIL | FLAGGSTAFF | AZ | 86001 |
| K031167 | IDT TECHNOLOGY LIMITED |
BLOCK C, 9/F., KAISER ESTATE, | HUNGHOM, HONG KONG | ||
| K050395 | IMPEDIMED PTY LTD. |
BUILDING 4B/2404 LOGAN ROAD | BRISBANE, QUEENSLAND | 4113 | |
| K052319 | IMPEDIMED PTY LTD. |
BUILDING 4B/2404 LOGAN ROAD | BRISBANE, QUEENSLAND | 4113 | |
| K130856 | IPGDX, LLC |
33 Golden Eagle Lane | Littleton | CO | 80127 |
| K140045 | JAWON MEDICAL CO., LTD. |
#1208-12, Sinsang-Li, Jinryang-Myun | Kyungsan-city, Kyungsan-Bukdo | 712-830 | |
| K072325 | JAWON MEDICAL CO., LTD. |
#1208-12, Sinsang-Li, Jinryang-Myun | Kyungsan-city, Kyungsan-Bukdo | 712-830 | |
| K092431 | JAWON MEDICAL CO., LTD. |
#1208-12, Sinsang-Li, Jinryang-Myun | Kyungsan-city, Kyungsan-Bukdo | 712-830 | |
| K053556 | JAWON MEDICAL CO., LTD. |
ROOM 624, LIFE OFFICETEL, 61-3 | SEOUL, KOREA | 150-731 | |
| K071884 | JAWON MEDICAL CO., LTD. |
#1208-12, Sinsang-Li, Jinryang-Myun | Kyungsan-city, Kyungsan-Bukdo | 712-830 | |
| K081587 | KRELL PRECISION (YANG ZHOU) CO., LTD. |
340 SHADY GROVE RD. | FLINTVILLE | TN | 37335-5031 |
| K103026 | L.D. TECHNOLOGY, LLC |
11459 NW 34 STREET | MIAMI | FL | 33178 |
| K052678 | LIMAX ELECTRONICS CO., LTD. |
2904 N. BOLDT DRIVE | FLAGSTAFF | AZ | 86001 |
| K030203 | LONG WELL ELECTRONICS CORP. |
3892 SOUTH AMERICA WEST TRAIL | FLAGSTAFF | AZ | 86001 |
| K010706 | MEASUREMENT SPECIALTIES, INC. |
21911 ERIE LN. | LAKE FOREST | CA | 92630 |
| K031582 | NIHON SEIMITSU SOKKI CO., LTD. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K062043 | OMRON HEALTHCARE, INC. |
3460 POINTE CREEK COURT #102 | BONITA SPRINGS | FL | 34134 |
| K011652 | OMRON HEALTHCARE, INC. |
300 LAKEVIEW PKWY. | VERNON HILLS | IL | 60061 |
| K963575 | OMRON HEALTHCARE, INC. |
300 LAKEVIEW PKWY. | VERNON HILLS | IL | 60061 |
| K043060 | OMRON HEALTHCARE, INC. |
3460 POINTE CREEK COURT #102 | BONITA SPRINGS | FL | 34134 |
| K130952 | PRECISION ONE LIFECARE, LTD. |
PO BOX 3515 | REDMOND | WA | 98073 |
| K070999 | RJL SYSTEMS, INC. |
33939 HARPER AVE. | CLINTON TWP | MI | 48035 |
| K023429 | ROWENTA, INC. |
196 BOSTON AVE. | MEDFORD | MA | 02155 |
| K122388 | SECA GMBH & CO. KG |
1300 I STREET, NW, 11TH FLOOR EAST | WASHINGTON | DC | 20005-3314 |
| K122976 | SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE |
77325 JOYCE WAY | ECHO | OR | 97826 |
| K112951 | SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
77325 JOYCE WAY | ECHO | OR | 97826 |
| K110928 | SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
77325 JOYCE WAY | ECHO | OR | 97826 |
| K121527 | SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
NO. 3. JINPING ROAD YA'AN | TIANJIN | 300190 | |
| K112149 | SHINE OVERSEAS MARKETING LIMITED |
77325 JOYCE WAY | ECHO | OR | 97826 |
| K052522 | STAYHEALTHY, INC. |
300 ELFWOOD DRIVE | MONROVIA | CA | 91016 |
| K101807 | STAYHEALTHY, INC. |
724 E. HUNTINGTON DRIVE | MONROVIA | CA | 91016 |
| K100183 | TANITA CORP. |
2625 SOUTH CLEARBROOK DRIVE | ARLINGTON HEIGHTS | IL | 60005 |
| K014009 | TANITA CORP. OF AMERICA |
2625 SOUTH CLEARBROOK DR. | ARLINGTON HGTS. | IL | 60005 |
| K040778 | TANITA CORP. OF AMERICA |
2625 SOUTH CLEARBROOK DR. | ARLINGTON HGTS. | IL | 60005 |
| K040978 | TANITA CORP. OF AMERICA |
2625 CLEARBROOK DR. | ARLINGTON HGTS. | IL | 60005 |
| K033157 | TANITA CORP. OF AMERICA |
2625 SOUTH CLEARBROOK DR. | ARLINGTON HGTS. | IL | 60005 |
| K062652 | TANITA CORPORATION OF AMERICA |
2625 SOUTH CLEARBROOK DRIVE | ARLINGTON HEIGHTS | IL | 60005 |
| K090479 | TANITA CORPORATION OF AMERICA |
2625 SOUTH CLEARBROOK DRIVE | ARLINGTON HEIGHTS | IL | 60005 |
| K023942 | YAMATO CORP. |
518 17TH ST. | DENVER | CO | 80202 |
| K111404 | ZHONGSHAN HUIBAO WEIGHING APPARATUS CO., LTD |
CHANGAN ROAD, GUZHEN TOWN | ZHONGSHAN CITY, GUANGDONG | 528421 | |
| K112932 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET | CHENGDU | 610041 | |
| K102191 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET | CHENGDU | 610041 | |
| K123781 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET | CHENGDU, SICHUAN | 610041 | |
| K121971 | ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
NO. 1 FANGHUA STREET | CHENGDU, SICHUAN | 610041 |
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