FDA 510(k) Applications for Medical Device:
Pack, Hot Or Cold, Water Circulating
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K970197 | ADROIT MEDICAL SYSTEMS, INC. |
1146 CARDING MACHINE RD. | LOUDON | TN | 37774 |
| K962983 | ADROIT MEDICAL SYSTEMS, INC. |
1146 CARDING MACHINE RD. | LOUDON | TN | 37774 |
| K961425 | BIO COMPRESSION SYSTEMS, INC. |
P.O. BOX 470218 | BROADVIEW HEIGHTS | OH | 44147 |
| K070402 | BREG, INC. |
2611 COMMERCE WAY | VISTA | CA | 92083 |
| K961855 | BREG, INC. |
2611 COMMERCE WAY | VISTA | CA | 92083 |
| K963596 | BREG, INC. |
2611 COMMERCE WAY | VISTA | CA | 92083 |
| K955326 | BURKE NEUTECH, INC. |
1765 COMMERCE AVE. NORTH | ST. PETERSBURG | FL | 33716 |
| K083008 | ELBIO CO., LTD |
845 ARONSON LAKE COURT | ROSWELL | GA | 30075 |
| K963261 | ELECTRO-BIOLOGY, INC. |
6 UPPER POND RD. | PARSIPPANY | NJ | 07054 |
| K073675 | GAYMAR INDUSTRIES, INC. |
140 PEARL STREET, SUITE 100 | BUFFALO | NY | 14202 |
| K962537 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K964006 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K973023 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K964057 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K072152 | JUNIPER MEDICAL INC. |
4698 WILLOW RD. | PLEASANTON | CA | 94588 |
| K955529 | MARK H. FRIEDMAN |
660 GRAMATAN AVE. | MOUNT VERNON | NY | 10522 |
| K040317 | MARK H. FRIEDMAN |
2 OVERHILL RD., STE 260 | SCARSDALE | NY | 10583 |
| K964710 | MED TECHNOLOGY, INC. |
2601 PINEWOOD | GRAND PRAIRIE | TX | 75051 |
| K954095 | MICROCLIMATE SYSTEMS, INC. |
965 SOUTH SAGINAW RD. | SANFORD | MI | 48657 |
| K964354 | ORMED GMBH |
1000 BURNETTE AVE., SUITE 450 | CONCORD | CA | 94520 |
| K964799 | ORMED GMBH |
1000 BURNETTE AVE., SUITE 450 | CONCORD | CA | 94520 |
| K213097 | Pain Management Technologies, Inc. |
1760 Wadsworth Rd. | Akron | OH | 44320 |
| K970533 | SMITH & NEPHEW, INC. |
2777 LOKER AVE., WEST | CARLSBAD | CA | 92008 |
| K955057 | SMITH AND NEPHEW DONJOY, INC. |
2777 LOKER AVENUE WEST | CARSBAD | CA | 92008-6601 |
| K961621 | THERAPY CONCEPTS, INC. |
15 FOXHUNT DR. | CHESTERFIELD | MO | 63017 |
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