FDA 510(k) Applications for Medical Device:
Mattress, Air Flotation, Alternating Pressure
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K963677 | 9TH WAVE, INC. |
PO BOX 1026 | MT. PLEASANT | SC | 29465-1026 |
| K963626 | 9TH WAVE, INC. |
PO BOX 1026 | MT. PLEASANT | SC | 29465-1026 |
| K963620 | 9TH WAVE, INC. |
PO BOX 1026 | MT. PLEASANT | SC | 29465-1026 |
| K970350 | ADVANCED AIR SUPPORT CONSULTANCY, INC. |
18554 RANCHERO RD. | HESPERIA | CA | 92345 |
| K970362 | APEX METAL, INC. |
3039 ROSWELL ST. | LOS ANGELES | CA | 90065 |
| K955874 | ASF INDUSTRIES, INC. |
221 CENTER BAY DR. | WEST ISLIP | NY | 11795 |
| K972022 | CARDIO SYSTEMS, INC. |
1201 NORTH INTERSTATE 35 | CARROLLTON | TX | 75006 |
| K970081 | CATHAY CONSOLIDATED, INC. |
P.O. BOX 333 | TAIPEI | ||
| K972153 | DECUBITI CONCEPTS, INC. |
PO BOX 1026 | MT. PLEASANT, | SC | 29465-1026 |
| K961854 | GAYMAR INDUSTRIES, INC. |
10 CENTRE DR. | ORCHARD PARK | NY | 14127 |
| K960411 | INVACARE CORP. |
899 CLEVELAND ST. | ELYRIA | OH | 44036 |
| K955243 | KINETIC CONCEPTS, INC. |
P.O. BOX 659508 | SAN ANTONIO | TX | 78216-9508 |
| K970468 | KINETIC CONCEPTS, INC. |
4958 STOUT DR. | SAN ANTONIO | TX | 78219 |
| K954320 | KINETIC CONCEPTS, INC. |
P.O. BOX 659508 | SAN ANTONIO | TX | 78265-9508 |
| K972549 | KINETIC CONCEPTS, INC. |
P.O. BOX 659508 | SAN ANTONIO | TX | 78265-9508 |
| K962123 | LUMEX, INC. |
100 SPENCE ST. | BAY SHORE | NY | 11706-2290 |
| K963674 | LUMEX, INC. |
100 SPENCE ST. | BAY SHORE | NY | 11706-2290 |
| K954593 | MARCON GROUP, INC. |
2000 M STREET, N.W. | WASHINGTON | DC | 20036 |
| K963510 | MELLEN AIR MFG., INC. |
2840 TEMPLE AVE. | LONG BEACH | CA | 90806 |
| K961129 | MELLEN AIR MFG., INC. |
2840 TEMPLE AVE. | LONG BEACH | CA | 90806 |
| K974070 | PHYSIO DESIGNS, INC. |
11 ARDEN LN. | COMMACK | NY | 11725 |
| K971568 | REST MATTRESS |
19636 CLUB HOUSE RD. | GAITHERSBURG | MD | 20879 |
| K970428 | RESTXSYS |
19636 CLUB HOUSE RD. | GAITHERSBURG | MD | 20879 |
| K961769 | ROBERT GOLD ASSOC. |
29 AINSWORTH AVE. | EAST BRUNSWICK | NJ | 08816 |
| K965207 | SKIN CARE MANAGEMENT, INC. |
29 AINSWORTH AVE. | EAST BRUNSWICK | NJ | 08816 |
| K961159 | SPAN-AMERICA MEDICAL SYSTEMS, INC. |
P.O. BOX 5231 | GREENVILLE | SC | 29606 |
| K954766 | SPAN-AMERICA MEDICAL SYSTEMS, INC. |
P.O. BOX 5231 | GREENVILLE | SC | 29606 |
| K973169 | SPAN-AMERICA MEDICAL SYSTEMS, INC. |
70 COMMERCE DR. | GREENVILLE | SC | 29615 |
| K960620 | SPAN-AMERICA MEDICAL SYSTEMS, INC. |
P.O. BOX 5231 | GREENVILLE | SC | 29606 |
| K960188 | SPAN-AMERICA MEDICAL SYSTEMS, INC. |
70 COMMERCE DR. | GREENVILLE | SC | 29615 |
| K962585 | UNITED MEDICAL EQUIPMENT, INC. |
17 HENRY AVE. | PARK RIDGE | NJ | 07656 |
| K974319 | WHEELCHAIRS OF KANSAS |
P.O. BOX 320 | ELLIS | KS | 67637 |
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