FDA 510(k) Applications for Medical Device:
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K160075 | Alma Lasers Inc. |
485 Half Day Rd. Ste 100 | Buffalo Grove | IL | 60089 |
| K161628 | Bonutti Research, Inc. |
P.O. Box 1367 | Effingham | IL | 62401 |
| K160378 | BRH Medical Ltd. |
The Jerusalem Technological Gardens | Jerusalem | 96951 | |
| K970131 | C.L. MCINTOSH & ASSOC., INC. |
12300 TWINBROOK PKWY. | ROCKVILLE | MD | 20852 |
| K202788 | Carci Industria E Comercio De Aparelhos Cirurgicos E Orto |
R. Padre Machado, 82 | Sao Paulo | 04127 | |
| K031116 | CHATTANOOGA GROUP |
4717 ADAMS RD. | HIXSON | TN | 37343 |
| K982829 | CHATTANOOGA GROUP, INC. |
4717 ADAMS RD. | HIXSON | TN | 37343 |
| K973024 | CHATTANOOGA GROUP, INC. |
4717 ADAMS RD. | HIXSON | TN | 37343 |
| K960802 | CUSHMAN MFG., INC. |
2786 TEMPLE AVE. | LONG BEACH | CA | 90806 |
| K961250 | DYNATRONICS CORP. |
7030 PARK CENTRE DR. | SALT LAKE CITY | UT | 84121 |
| K031329 | DYNATRONICS CORP. |
7030 PARK CENTRE DR. | SALT LAKE CITY | UT | 84121 |
| K230472 | Enraf-Nonius, B.V. |
127, Vareseweg | Rotterdam | NL-3047AT | |
| K984199 | FIBRA SONICS, INC. |
5312 N. ELSTON AVE. | CHICAGO | IL | 60630 |
| K161502 | GENERAL PROJECT S.R.L. |
VIA DELLA GORA 15/19 | MONTESPERTOLI | 50025 | |
| K091615 | GENERAL PROJECT S.R.L. |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K053041 | GENERAL PROJECT S.R.L. |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K000084 | HENLEY HEALTHCARE, INC. |
120 INDUSTRIAL BLVD. | SUGAR LAND | TX | 77478 |
| K062256 | HILL LABORATORIES CO. |
3 BACTON HILL RD. | FRAZER | PA | 19355 |
| K040798 | HWANG SUN ENTERPRISE CO., LTD. |
30 NORTHPORT ROAD | SOUND BEACH | NY | 11789 |
| K050410 | HWANG SUN ENTERPRISE CO., LTD. |
11 HEATHER COURT | MIDDLE ISLAND | NY | 11953 |
| K131309 | IBRAMED EQUIPAMENTOS MEDICOS |
18851 NE 29TH AVE 720 | AVENTURA | FL | 33180 |
| K130888 | IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI |
18851 NE 29TH AVE, 720 | AVENTURA | FL | 33180 |
| K032793 | ITO CO., LTD. |
2305 GOLD MINE RD. | BROOKEVILLE | MD | 20833 |
| K112520 | ITO CO., LTD. |
3-3-3 TOYOTAMA-MINAMI | TOKYO | 176-0014 | |
| K240788 | JKH Health Co., Ltd. |
4-5F, Building 12, Hengmingzhu Industrial Park, | Shenzhen | 518104 | |
| K010702 | KMI KOLSTER METHODS, INC. |
1170 N. GILBERT ST. | ANAHEIM | CA | 92801 |
| K210284 | ManaMed, Inc. |
5240 W. Charleston Blvd. | Las Vegas | NV | 89146 |
| K222098 | ManaMed, Inc. |
5240 W. Charleston Blvd. | Las Vegas | NV | 89146 |
| K954136 | MATRIX BIOKINETICS, INC. |
4208 ARCATA WAY, UNIT C | NORTH LAS VEGAS | NV | 89030 |
| K030410 | METRON MEDICAL AUSTRALIA PTY LTD |
57 ASTER AVE. | CARRUM DOWNS, VICTORIA | 3201 | |
| K120171 | METRON MEDICAL AUSTRALIA PTY LTD |
57 ASTER AVE. | CARRUM DOWNS | 3201 | |
| K124010 | METRON MEDICAL AUSTRALIA PTY LTD |
57 ASTER AVE. | CARRUM DOWNS, VICTORIA | 3201 | |
| K001370 | METRON MEDICAL AUSTRALIA PTY LTD |
57 ASTER AVE. | CARRUM DOWNS, VICTORIA | 3201 | |
| K010609 | METRON MEDICAL AUSTRALIA PTY LTD |
57 ASTER AVE. | CARRUM DOWNS, VICTORIA | 3201 | |
| K011955 | METRON MEDICAL AUSTRALIA PTY LTD |
57 ASTER AVE. | CARRUM DOWNS, VICTORIA | 3201 | |
| K010102 | METRON MEDICAL AUSTRALIA PTY LTD |
57 ASTER AVE. | CARRUM DOWNS, VICTORIA | 3201 | |
| K000593 | METRON MEDICAL AUSTRALIA PTY LTD |
57 ASTER AVE. | CARRUM DOWNS, VICTORIA | 3201 | |
| K030878 | METRON MEDICAL AUSTRALIA, PTY, LTD. |
57 ASTER AVE., P.O. BOX 2164 | CARRUM DOWNS, VICTORIA | 3201 | |
| K053546 | METTLER ELECTRONICS CORP. |
1333 SOUTH CLAUDINA ST. | ANAHEIM | CA | 92805 |
| K013192 | METTLER ELECTRONICS CORP. |
1333 SOUTH CLAUDINA ST. | ANAHEIM | CA | 92805 |
| K000604 | NATUROPATHIC LABORATORIES INTERNATIONAL, INC. |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
| K021483 | RICH-MAR CORP. |
P.O. BOX 879 | INOLA | OK | 74036 |
| K982544 | RICH-MAR CORP. |
P.O. BOX 879 | INOLA | OK | 74036 |
| K052934 | S.O.R. INTERNACIONAL, S.A. |
2454 MCMULLEN BOOTH ROAD | SUITE 427, CLEARWATER | FL | 33759 |
| K142976 | Shenzhen Dongdixin Technology Co., Ltd |
No. 3 Building, XiLiBaimang Industrial Estate | Shenzhen | 518108 | |
| K981449 | SKYLARK DEVICE CO., LTD. |
34 CHUNG SHAN NORTH RD., | TAIPEI | ||
| K991613 | STARBENE |
DAVID LUQUE 519 | CORDOBA, PVCIA. CORDOBA | 5000 | |
| K090542 | SUN-RAIN SYSTEM CORP. |
NO. 58, FU-CHIUN ST. | HSIN-CHU CITY | ||
| K024013 | SUN-RAIN SYSTEM CORP. |
NO. 58, FU-CHIUN ST. | HSIN-CHU CITY | ||
| K024307 | SYBARITIC, INC. |
9220 JAMES AVE. SOUTH | BLOOMINGTON | MN | 55431 |
| K952536 | ZIMMER ELEKTROMEDIZIN GMBH |
9 JUNKERSSTRABE | D7910 NEU-ULM |
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