FDA 510(k) Applications for Medical Device:
Needle, Acupuncture, Single Use
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K990729 | ACC INTL. |
108 N. YNEZ AVE. | MONTEREY PARK | CA | 91754 |
| K960769 | ACU-MED, INC. |
2701 WEST ALAMEDA AVE., #301 | BURBANK | CA | 91505 |
| K962419 | ACUPUNCTURE SUPPLIES IMPORT CO. |
11306 EAST 183RD ST., #202 | CERRITOS | CA | 90703 |
| K962787 | ACUPUNCTURE SUPPLIES IMPORT CO. |
11306 EAST 183RD ST., #202 | CERRITOS | CA | 90703 |
| K011248 | ACUSUPPLY, INC. |
3801 NE 207TH ST., SUITE 501 | AVENTURA | FL | 33180 |
| K011247 | ACUSUPPLY, INC. |
3801 NE 207TH ST., SUITE 501 | AVENTURA | FL | 33180 |
| K011242 | ACUSUPPLY, INC. |
3801 NE 207TH ST. | AVENTURA | FL | 33180 |
| K980471 | AMERICAN INSTITUTE OF KORYO HAND THERAPY |
17870 CASTLETON ST., STE. 265 | INDUSTRY | CA | 91748 |
| K974527 | AMERICAN INSTITUTE OF KORYO HAND THERAPY |
1800 CENTURY PARK EAST. | LOS ANGELES | CA | 90067 |
| K980472 | AMERICAN INSTITUTE OF KORYO HAND THERAPY |
17870 CASTLETON ST., STE. 265 | INDUSTRY | CA | 91748 |
| K980470 | AMERICAN INSTITUTE OF KORYO HAND THERAPY |
17870 CASTLETON ST., STE. 265 | INDUSTRY | CA | 91748 |
| K980469 | AMERICAN INSTITUTE OF KORYO HAND THERAPY |
17870 CASTLETON ST., STE. 265 | INDUSTRY | CA | 91748 |
| K002910 | ANC IMPORT & EXPORT CO. LTD. |
4309 MURWICK DR. | ARLINGTON | TX | 76016 |
| K000740 | ASAHI IRYOKI CO. LTD |
10 NEW KING ST. | WHITE PLAINS | NY | 10604 |
| K042063 | ASIA-MED GMBH & CO. KG. - WERK SUHL |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K011808 | ASIA-MED GMBH AND CO KG |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K132896 | ASIA-MED GMBH AND CO KG |
33 Golden Eagle Lane | Littleton | CO | 80127 |
| K031716 | ASIA-MED GMBH AND CO KG |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K052085 | ASIA-MED GMBH AND CO KG |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K103061 | BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. |
NO.45, MINSHENG RD. | TAIPEI COUNTY | 251 | |
| K041652 | C.A.I. INDUSTRIES CORP. |
10166 RUSH ST. | SOUTH EL MONTE | CA | 91007 |
| K970574 | C.A.I. INDUSTRIES CORP. |
800 SOUTH PALM AVE. SUITE 10 | ALHAMBRA | CA | 91803 |
| K964861 | C.A.M. SUPPLY, INC. |
865 S. FIGUEROA ST., | LOS ANGELES | CA | 90017 |
| K162566 | CHANGCHUN AIK MEDICAL DEVICES CO., LTD |
NO. 25, KAREN INDUSTRIAL PARK, | CHANGCHUN | 130507 | |
| K052731 | DAXIN LI |
2600 MISSION STREET, SUITE 100 | SAN MARINO | CA | 91108 |
| K972659 | DONG BANG, U.S.A. |
13640 EAST IMPERIAL HWY., #1 | SANTA FE SPRINGS | CA | 90670 |
| K972658 | DONG BANG, U.S.A. |
13640 EAST IMPERIAL HWY., #1 | SANTA FE SPRINGS | CA | 90670 |
| K981272 | ELECTRO THERAPEUTIC DEVICES, INC. |
570 HOOD RD., STE. 14 | MARKHAM, ONTARIO | L3R 4G7 | |
| K031818 | FACILAI ENTERPRISES LTD. |
NO. 58, FU-CHIUN ST. | HSIN-CHU CITY | 300 | |
| K011669 | H F INTL. CO. |
865 SOUTH FIGUEROA ST. | LOS ANGELES | CA | 90017 |
| K002827 | HAENGLIM SEOWON CORP. |
34-69 LEAVITT ST. | FLUSHING | NY | 11354 |
| K092240 | HAENGLIM SEOWON MEDICAL CO. |
1705 S. CAPITAL OF TEXAS HWY | AUSTIN | TX | 78746 |
| K090910 | HANSOL MEDICAL CO. |
300 ATWOOD ST. | PITTSBURGH | PA | 15213 |
| K012583 | HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. | SAN JOSE | CA | 95131 |
| K991508 | HELIO MEDICAL SUPPLIES, INC. |
2080A WALSH AVE. | SANTA CLARA | CA | 95050 |
| K072778 | HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. | SAN JOSE | CA | 95131 |
| K043277 | HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. | SAN JOSE | CA | 95131 |
| K961339 | HELIO MEDICAL SUPPLIES, INC. |
2080A WALSH AVE. | SANTA CLARA | CA | 95050 |
| K991507 | HELIO MEDICAL SUPPLIES, INC. |
2080A WALSH AVE. | SANTA CLARA | CA | 95050 |
| K062448 | HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. | SAN JOSE | CA | 95131 |
| K050295 | HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. | SAN JOSE | CA | 95131 |
| K052723 | HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. | SAN JOSE | CA | 95131 |
| K024207 | HELIO MEDICAL SUPPLIES, INC. |
606 CHARCOT AVE. | SAN JOSE | CA | 95131 |
| K012501 | HUMMINGBIRD MEDICAL TECHNOLOGY, L.L.C. |
1427 GREENBRIAR DR. | ALLEN | TX | 75013 |
| K142920 | K.M.S. INC. |
F2, 81-1 HAENFJEONG-RI, GWANGDEOK-MYEON, DONGNAM-GU | CHEONAN-SI | 330922 | |
| K961677 | K.S. CHOI CORP. |
3932 WILSHIRE BLVD., #300 | LOS ANGELES | CA | 90010 |
| K142760 | K.S. Choi Corporation |
179 W39th St | Los Angeles | CA | 90037 |
| K980899 | KENSHIN TRADING CORP. |
1815 WEST 213TH ST., SUITE 180 | TORRANCE | CA | 90501 |
| K964529 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K963300 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K031250 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K962916 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K963299 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K031060 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K003760 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K023787 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K964411 | LHASA MEDICAL, INC. |
234 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K974616 | LORAC, INC. |
134 NORTH WASHINGTON ST. | NAPERVILLE, | IL | 60540 |
| K150903 | MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. |
1358 Meishan Road, Economic & Technology Development Zone | Maanshan | 243041 | |
| K052846 | MAANSHAN MEDICAL INSTRUMENTS CO., LTD. |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K000581 | MAEDA TOYOKICHI SHOTEN |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K021904 | MAEDA TOYOKICHI SHOTEN |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K023054 | MANDALA HEALTH CARE, LLC |
4320 SPRING VALLEY RD., | DALLAS | TX | 75244-4352 |
| K043506 | MARKNEW PRODUCTS |
3722 AVE, SAUSALITO | IRVINE | CA | 92606 |
| K020880 | MARKNEW PRODUCTS |
3722 AVE, SAUSALITO | IRVINE | CA | 92606 |
| K990328 | MORNING STAR, DONG BANG ACUPUNCTURE U.S.A., INC. |
1429 LYNDON ST. | SOUTH PASADENA | CA | 91030 |
| K963194 | OMS MEDICAL SUPPLIES, INC. |
230 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K061517 | PRIME HERBS CORPORATION |
754 SAN ALESO AVE. | SUNNYVALE | CA | 94085 |
| K964051 | S-TCM ENTERPRISES, INC. |
13010 RESEARCH BLVD., | AUSTIN | TX | 78750 |
| K974122 | SCIENTIFIC HEALTH CARE |
1491 BAKER STREET, SUITE 1 | COSTA MESA | CA | 92626 |
| K060392 | SEDATELEC |
13 RED FOX LANE | LITTLETON | CO | 80127 |
| K983800 | SEDATELEC |
200 GREGORY LANE, SUITE C-100 | PLEASANT HILL | CA | 94523-3389 |
| K983798 | SEDATELEC |
200 GREGORY LANE, SUITE C-100 | PLEASANT HILL | CA | 94523-3389 |
| K962809 | SEIRIN-AMERICA, INC. |
230 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K970260 | SEIRIN-AMERICA, INC. |
230 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K970254 | SEIRIN-AMERICA, INC. |
230 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K963769 | SEIRIN-AMERICA, INC. |
230 LIBBEY PKWY. | WEYMOUTH | MA | 02189 |
| K002411 | SHENLING MEDICAL DEVICE CO., LTD |
1800 CENTURY PARK EAST | LOS ANGELES | CA | 90067-1509 |
| K141473 | SMC INTL., INC. |
JISAN IT VENTURE CENTER 601 | SEOUL | 153-289 | |
| K030190 | SUZHOU SEN SEN MEDICAL SUPPLIES LTD. |
4500 SHEPPARD AVE. EAST | ONTARIO | ||
| K003748 | SUZHOU TIANYI ACUPUNCTURE INSTRUMENTS CO., LTD. |
1491 BAKER ST. | COSTA MESA | CA | 92626 |
| K983671 | TCM SUPPLY CORP. |
12490 CENTRAL AVE., SUITE 221 | CHINO | CA | 91710 |
| K000816 | TCM SUPPLY CORP. |
15946 KAPLAN AVE. | CITY OF INDUSTRY | CA | 91744 |
| K071524 | TCM WORLD INC. |
1512 PROSPECT AVE. UNIT D | SAN GABRIEL | CA | 91776 |
| K990406 | UNITED PACIFIC CO., LTD. |
219 SOUTH RAYMOND AVE. | ALHAMBRA | CA | 91801 |
| K001718 | UNITED PACIFIC CO., LTD. |
219 SOUTH RAYMOND AVE. | ALHAMBRA | CA | 91801 |
| K003010 | UNITED PACIFIC CO., LTD. |
219 SOUTH RAYMOND AVE. | ALHAMBRA | CA | 91801 |
| K111392 | WOOJEON COMPANY |
300 ATWOOD | PITTSBURGH | PA | 15213 |
| K021095 | WUJIANG CITY HUA XIN MEDICAL APPLIANCE CO., LTD. |
10 WESTMONT RD. | CANDLER | NC | 28715 |
| K013926 | WUJIANG CITY SHENLI MEDICAL AND HEALTH MATERIAL CO |
503 ROOM, 8 BUILDING, | SHANGHI | 200233 | |
| K090199 | WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
QINGHONG RD., EHU TOWN | WUXI, JIANGSU | 214116 |
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