FDA 510(k) Applications for Medical Device:
Restraint, Protective
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K963528 | ALIMED, INC. |
1200 EAST ST. | DEDHAM | MA | 02026 |
| K963526 | ALIMED, INC. |
1200 EAST ST. | DEDHAM | MA | 02026 |
| K963527 | ALIMED, INC. |
1200 EAST ST. | DEDHAM | MA | 02026 |
| K963138 | BDM MEDICAL, INC. |
518 MAIN ST. | ASHTON | ID | 83420 |
| K991591 | BIOPLASTICS |
34655 MILLS RD. | N. RIDGEVILLE | OH | 44039 |
| K963462 | BIRD & CRONIN, INC. |
1200 TRAPP RD. | SAINT PAUL | MN | 55121 |
| K972446 | CAVITY FREE KIDS, INC. |
1224 ARCADE ST. | ST. PAUL | MN | 55106 |
| K081264 | CHILDREN'S HEALTH FIRST, INC. |
5249 SHELLEY PLACE | CARLSBAD | CA | 92008 |
| K963453 | CONTOUR FABRICATORS, INC. |
4100 E. BALDWIN AVE. | GRAND BLANC | MI | 48439 |
| K971742 | DEPUY, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K963393 | DEPUY, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K963470 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963476 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963469 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963466 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963477 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963472 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963465 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963464 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963468 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963473 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963467 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963478 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963463 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963471 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K963474 | DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. | POWELL | TN | 37849 |
| K971948 | E.M. ADAMS CO., INC. |
7496 COMMERCIAL CIRCLE | FORT PIERCE | FL | 34951 |
| K971536 | E.M. ADAMS CO., INC. |
7496 COMMERCIAL CIRCLE | FORT PIERCE | FL | 34951 |
| K982178 | EMERGENT INNOVATIONS, LTD. |
PO BOX 40773 | INDIANAPOLIS | IN | 46240 |
| K970272 | FLA. ORTHOPEDICS, INC. |
5858 N.W. 158TH ST., | MIAMI LAKES | FL | 33014-1380 |
| K970273 | FLA. ORTHOPEDICS, INC. |
5757 NW 158TH ST. | MIAMI LAKES | FL | 33014 |
| K970274 | FLA. ORTHOPEDICS, INC. |
5757 NW 158TH ST. | MIAMI LAKES | FL | 33014 |
| K970275 | FLA. ORTHOPEDICS, INC. |
5757 NW 158TH ST. | MIAMI LAKES | FL | 33014 |
| K972338 | GERIATRIC PRODUCTS, INC. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K972046 | GILLEN INDUSTRIES |
ONE RICHMOND SQ. STE. 180 | PROVIDENCE | RI | 02906 |
| K962810 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963243 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963372 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963237 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963041 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963099 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K962839 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K962832 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K962834 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963060 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K980640 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963294 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K962831 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K962778 | HEELBO, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K962963 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K962964 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963199 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963108 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963485 | HUMANE RESTRAINT, INC. |
912 BETHEL CIRCLE | WAUNAKEE | WI | 53597 |
| K963442 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K963414 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K963413 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K963439 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K963437 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K963409 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K963411 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K963410 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K963436 | J. T. POSEY CO. |
5635 PECK RD. | ARCADIA | CA | 91006 |
| K971561 | JEMM MEDICAL PRODUCTS |
42909 ALEP ST. | LANCASTER | CA | 93536 |
| K962429 | JOHNSON & JOHNSON PROFESSIONALS, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K962626 | KENAD SG MEDICAL, INC. |
2692 HUNTLEY DR. | MEMPHIS | TN | 38132 |
| K963422 | KENAD SG MEDICAL, INC. |
2692 HUNTLEY DR. | MEMPHIS | TN | 38132 |
| K963430 | KENAD SG MEDICAL, INC. |
2692 HUNTLEY DR. | MEMPHIS | TN | 38132 |
| K963421 | KENAD SG MEDICAL, INC. |
2692 HUNTLEY DR. | MEMPHIS | TN | 38132 |
| K013239 | MED GEN, INC. |
7284 W. PALMETTO PK. RD. | BOCA RATON | FL | 33433-3406 |
| K110377 | MEDI-TECH INTL. CORP. |
26 COURT ST., SUITE 1301 | BROOKLYN | NY | 11242 |
| K963504 | MEDLINE |
ONE MEDLINE PLACE | MUNDLELEIN | IL | 60060 |
| K963452 | MEDLINE |
ONE MEDLINE PLACE | MUNDLELEIN | IL | 60060 |
| K963360 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060-4486 |
| K963378 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060-4486 |
| K963404 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K963362 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K963569 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K963416 | MORRISON MEDICAL PRODUCTS |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963371 | MORRISON MEDICAL PRODUCTS |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963370 | MORRISON MEDICAL PRODUCTS |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963387 | MORRISON MEDICAL PRODUCTS |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963494 | MORRISON MEDICAL PRODUCTS |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963399 | MORRISON MEDICAL PRODUCTS |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963419 | MORRISON MEDICAL PRODUCTS |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963374 | MORRISON MEDICAL PRODUCTS |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K963547 | SAFE RESTRAINTS, INC. |
1500 NEWELL AVE. | WALNUT CREEK | CA | 94596 |
| K963906 | SAFETY INTL., INC. |
P.O. BOX 18-2236 | CASSELBERRY | FL | 32718-2236 |
| K962327 | SEKURE SEAT CORP. |
764 8TH AVE. S.E. | HICKORY | NC | 28602 |
| K010644 | SKIL-CARE CORP. |
29 WELLS AVE. | YONKERS | NY | 10701 |
| K963454 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K963447 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K963448 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K010818 | SKIL-CARE CORP. |
29 WELLS AVE. | YONKERS | NY | 10701 |
| K963456 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K963458 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K963449 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K963460 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K963450 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K963457 | SKIL-CARE CORP. |
167 SAW MILL RIVER RD. | YONKERS | NY | 10701 |
| K972123 | SMITH |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K963492 | SMITH AND NEPHEW DONJOY, INC. |
2985 SCOTT ST. | VISTA | CA | 92083 |
| K963490 | SMITH AND NEPHEW DONJOY, INC. |
2985 SCOTT ST. | VISTA | CA | 92083 |
| K963489 | SMITH AND NEPHEW DONJOY, INC. |
2985 SCOTT ST. | VISTA | CA | 92083 |
| K963491 | STUCKEY ENT., INC. |
13629 CATAMARAN | CORPUS CHRISTI | TX | 78418 |
| K963554 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K963773 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K963564 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K963552 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K963556 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K963557 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K963561 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K963563 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K963559 | TECNOL MEDICAL PRODUCTS, INC. |
7201 INDUSTRIAL PARK BLVD. | FORT WORTH | TX | 76180 |
| K080448 | TRI-STATE HOSPITAL SUPPLY CORP. |
301 CATRELL DR. | HOWELL | MI | 48843 |
| K963435 | ZIMMER PATIENT CARE DIVISION |
200 WEST OHIO AVE. | DOVER | OH | 44622 |
| K963431 | ZIMMER, INC. |
200 W. OHIO AVE. | DOVER | OH | 44622 |
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