FDA 510(k) Applications for Medical Device:
Device, Counter-Pulsating, External
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K042413 | APPLIED CARDIAC SYSTEMS |
22912 EL PACIFICO DR. | LAGUNA HILLS | CA | 92653 |
| K050172 | CARDIOMEDICS, INC. |
18872 BARDEEN AVE. | IRVINE | CA | 92612 |
| K022107 | CARDIOMEDICS, INC. |
18872 BARDEEN AVE. | IRVINE | CA | 92612 |
| K023427 | CARDIOMEDICS, INC. |
18872 BARDEEN AVE. | IRVINE | CA | 92612 |
| K010261 | CARDIOMEDICS, INC. |
18872 BARDEEN AVE. | IRVINE | CA | 92612 |
| K130439 | CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD |
05C. FUHAI KANGLE BUILDING NANSHAN DISTRICT SHENZHEN, CHINA | SHENZHEN, GUANGDONG | 518000 | |
| K082134 | CIRCULATOR BOOT CORP. |
72 PENNSYLVANIA AVE. | MALVERN | PA | 19355 |
| K971026 | CIRCULATOR BOOT CORP. |
150 MILL CREEK RD. | ARDMORE | PA | 19003 |
| K030532 | CPCA2000 INC |
6336 17TH ST. CIRCLE EAST | SARASOTA | FL | 34243 |
| K052611 | ECP HEALTH INC. |
8416 PRAIRIE ROSE LANE | FORT WORTH | TX | 76123 |
| K021340 | EXTERNAL COUNTERPULSATION LAB |
85 WU JIN ROAD | SHANGHAI | 200080 | |
| K012141 | EXTERNAL COUNTERPULSATION LAB |
BEIT HAPA'AMON (BOX 124) | KFAR SABA | 44425 | |
| K023701 | LIVING DATA TECHNOLOGIES CORPORATION |
55 NORTHERN BLVD. SUITE 200 | GREAT NECK | NY | 11021 |
| K033657 | LIVING DATA TECHNOLOGIES CORPORATION |
55 NORTHERN BLVD. SUITE 200 | GREAT NECK | NY | 11021 |
| K980937 | NICORE EQUIPMENT & LEASING, INC. |
1625 K STREET, NW, SUITE 1000 | WASHINGTON | DC | 20006-1604 |
| K023016 | NICORE EQUIPMENT & LEASING, INC. |
4897 W. WATERS AVE., SUITE J | TAMPA | FL | 33634 |
| K191955 | Omay(Guangzhou)Med Technologies Co., Ltd. |
Room 302,3F, No. 600-1, Guangshan 2nd Road, Tianhe | Guangzhou | ||
| K030587 | S-TCT HEALTH INC. |
2020 PONCE DE LEON BLVD., SUITE 1101 | CORAL GABLES | FL | 33134 |
| K081359 | SCOTTCARE CORPORATION |
4791 WEST 150TH ST. | CLEVELAND | OH | 44135 |
| K022078 | SOLA MEDICAL DEVICES, LLC |
3722 AVE SAUSALITO | IRVINE | CA | 92606 |
| K152115 | Stage 2 Innovations |
7811 Montrose Rd | Rockville | MD | 20854 |
| K190683 | Vamed Medical Instrument Co., Ltd |
1 of 8 Floor, 2# Building, No. 60, Lang bao West Road, | Foshan | 528000 | |
| K202108 | Vamed Medical Instrument Co., Ltd. |
1 of 8 Floor, 2# Building, No. 60, Langbao West Road, | Foshan | 413200 | |
| K020857 | VASOMEDICAL, INC. |
180 LINDEN AVE. | WESTBURY | NY | 11590 |
| K033617 | VASOMEDICAL, INC. |
180 LINDEN AVE. | WESTBURY | NY | 11590 |
| K003469 | VASOMEDICAL, INC. |
180 LINDEN AVE. | WESTBURY | NY | 11590 |
| K173483 | Xtreem Pulse, LLC |
353 W 29 St., Suite 3 | New York | NY | 10001 |
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