Guest guest Posted February 21, 2003 Report Share Posted February 21, 2003 Gail, Is this the section you need? FDA Cleared Cranial Remolding Orthoses “The FDA regulates cranial remolding orthoses to assure their safety and effectiveness. These rules regulate various aspects of the design, clinical evaluation, manufacturing, packaging, labeling, commercial distribution and postmarket surveillance of cranial remolding orthoses.”[1] It is important for parents to make sure their infant receives an FDA cleared orthotic design. The following information is provided to assist parents in their efforts to find effective orthotic care for their infants. All orthotic designs and manufacturers listed below adhere to the strict guidelines established by the FDA in regards to the manufacture of cranial remolding orthoses for positional plagiocephaly. 510(k) Number Name of Orthosis Applicant Date of Clearance K021918 Clarren Helmet (Orthomerica) Orthomerica Products, Inc. 6333 N. Orange Blossom Trail Orlando, FL 32810 07/25/02 K021207 STARlight Cranial Remolding Orthosis Orthomerica Products, Inc. 6333 N. Orange Blossom Trail Orlando, FL 32810 07/09/02 K021221 O & P Cranial Molding Helmet Orthotic & Prosthetic Lab, Inc. 748 Marshall Ave. Webster Groves, MO 63119 07/01/02 K020448 Static Cranioplasty Orthosis Eastern Cranial Affiliates 2525 North Tenth Street, #804 Arlington, VA 22201 04/12/2002 K013700 Orthosis Helmet Molding Precision Prosthetics & Orthotics, Inc. 5353 Wayzata Blvd., #505 Minneapolis, MN 55416-1334 02/05/2002 K013719 Becker Band Cranial Remolding Orthosis Becker Orthopedic Appliance Co. 635 Executive Dr. Troy, MI 48083 02/05/2002 K014012 DOC Band Cranial Technologies, Inc. 1395 West Auto Dr. Tempe, AZ 85284 01/28/2002 K012804 Plagiocephalic Applied Pressure Orthosis Fit-Well Prosthetic and Orthotic Center 50 South 900 East, #1 Salt Lake City, UT 84102 01/17/2002 510(k) Number Name of Orthosis Applicant Date of Clearance K012920 Molded Cranial Helmet Fairview Orthopedic Laboratory 220 S. 6th Street Minneapolis, MN 55402-1498 11/28/2001 K012830 Lerman & Son Cranial Orthosis Helmet Lerman & Son 8710 Wilshire Blvd. Beverly Hills, CA 90211 11/20/2001 K013458 Cranial Helmet Children’s Hospital 5353 Wayzata Blvd. Minneapolis, MN 55416-1334 10/29/2001 K012007 RHS Helmet Restorative Health Svs., Inc. 1301 K Street, N.W. Suite 1100 – East Tower Washington, DC 20005-3373 09/19/2001 K011350 STARband Cranial Remolding Orthosis Orthomerica Products, Inc. 6333 N. Orange Blossom Trail Orlando, FL 32810 07/03/2001 K011433 Ballert Cranial Molding Helmet GEMA, Inc. 2434 W. Ave. Chicago, IL 60659 06/12/2001 K003035 Clarren Helmet Children’s Hospital & Medical Center 1301 K Street, N.W., #1100 Washington, DC 20005 06/06/2001 K003630 Michigan Cranial Helmet Danmar Products, Inc. 221 Industrial Dr. Ann Arbor, MI 48103 05/29/2001 K010273 Cranial Molding Orthosis Orthotic Solutions, Inc. 2802 Merrilee Dr., #100 Fairfax, VA 22031 04/25/2001 K001669 Hanger Cranial Band Hanger Orthopedic Group, Inc. 2 Bethesda Metro Center Bethesda, MD 20814 12/08/2000 K000861 Craniocap Gillette Children’s Specialty Healthcare 1785 Gold Court Eagan, MN 55122 10/30/2000 K001167 OPI Band Orthomerica Products, Inc. 6333 N. Orange Blossom Trail Orlando, FL 32810 07/07/2000 -----Original Message----- From: Gail [mailto:momofivftwins@...] Sent: Friday, February 21, 2003 11:14 AM Plagiocephaly Subject: file help Hey ya'll, Can anyone help me? I'm contacting the FDA today, and I'm trying to get a look at the document in the files section about FDA approved devices. Every time I try to open the file my virus software kicks in and says that a malicious script has been detected. Anyone else having this problem? Can someone look at the document and copy and paste the part about DOC bands into an email for me? Thanks for the help. Gail For more plagio info Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 21, 2003 Report Share Posted February 21, 2003 Yes, thank you very much . I finally got it to work enough that I got the 510(k) number and just called the FDA directly. They're faxing a letter today on our behalf. Gail ---- Original Message ----- From: Lanham Plagiocephaly Sent: Friday, February 21, 2003 12:11 PM Subject: RE: file help Gail, Is this the section you need? FDA Cleared Cranial Remolding Orthoses “The FDA regulates cranial remolding orthoses to assure their safety and effectiveness. These rules regulate various aspects of the design, clinical evaluation, manufacturing, packaging, labeling, commercial distribution and postmarket surveillance of cranial remolding orthoses.”[1] It is important for parents to make sure their infant receives an FDA cleared orthotic design. The following information is provided to assist parents in their efforts to find effective orthotic care for their infants. All orthotic designs and manufacturers listed below adhere to the strict guidelines established by the FDA in regards to the manufacture of cranial remolding orthoses for positional plagiocephaly. 510(k) Number Name of Orthosis Applicant Date of Clearance K021918 Clarren Helmet (Orthomerica) Orthomerica Products, Inc. 6333 N. Orange Blossom Trail Orlando, FL 32810 07/25/02 K021207 STARlight Cranial Remolding Orthosis Orthomerica Products, Inc. 6333 N. Orange Blossom Trail Orlando, FL 32810 07/09/02 K021221 O & P Cranial Molding Helmet Orthotic & Prosthetic Lab, Inc. 748 Marshall Ave. Webster Groves, MO 63119 07/01/02 K020448 Static Cranioplasty Orthosis Eastern Cranial Affiliates 2525 North Tenth Street, #804 Arlington, VA 22201 04/12/2002 K013700 Orthosis Helmet Molding Precision Prosthetics & Orthotics, Inc. 5353 Wayzata Blvd., #505 Minneapolis, MN 55416-1334 02/05/2002 K013719 Becker Band Cranial Remolding Orthosis Becker Orthopedic Appliance Co. 635 Executive Dr. Troy, MI 48083 02/05/2002 K014012 DOC Band Cranial Technologies, Inc. 1395 West Auto Dr. Tempe, AZ 85284 01/28/2002 K012804 Plagiocephalic Applied Pressure Orthosis Fit-Well Prosthetic and Orthotic Center 50 South 900 East, #1 Salt Lake City, UT 84102 01/17/2002 510(k) Number Name of Orthosis Applicant Date of Clearance K012920 Molded Cranial Helmet Fairview Orthopedic Laboratory 220 S. 6th Street Minneapolis, MN 55402-1498 11/28/2001 K012830 Lerman & Son Cranial Orthosis Helmet Lerman & Son 8710 Wilshire Blvd. Beverly Hills, CA 90211 11/20/2001 K013458 Cranial Helmet Children’s Hospital 5353 Wayzata Blvd. Minneapolis, MN 55416-1334 10/29/2001 K012007 RHS Helmet Restorative Health Svs., Inc. 1301 K Street, N.W. Suite 1100 – East Tower Washington, DC 20005-3373 09/19/2001 K011350 STARband Cranial Remolding Orthosis Orthomerica Products, Inc. 6333 N. Orange Blossom Trail Orlando, FL 32810 07/03/2001 K011433 Ballert Cranial Molding Helmet GEMA, Inc. 2434 W. Ave. Chicago, IL 60659 06/12/2001 K003035 Clarren Helmet Children’s Hospital & Medical Center 1301 K Street, N.W., #1100 Washington, DC 20005 06/06/2001 K003630 Michigan Cranial Helmet Danmar Products, Inc. 221 Industrial Dr. Ann Arbor, MI 48103 05/29/2001 K010273 Cranial Molding Orthosis Orthotic Solutions, Inc. 2802 Merrilee Dr., #100 Fairfax, VA 22031 04/25/2001 K001669 Hanger Cranial Band Hanger Orthopedic Group, Inc. 2 Bethesda Metro Center Bethesda, MD 20814 12/08/2000 K000861 Craniocap Gillette Children’s Specialty Healthcare 1785 Gold Court Eagan, MN 55122 10/30/2000 K001167 OPI Band Orthomerica Products, Inc. 6333 N. Orange Blossom Trail Orlando, FL 32810 07/07/2000 -----Original Message-----From: Gail [mailto:momofivftwins@...]Sent: Friday, February 21, 2003 11:14 AMPlagiocephaly Subject: file help Hey ya'll, Can anyone help me? I'm contacting the FDA today, and I'm trying to get a look at the document in the files section about FDA approved devices. Every time I try to open the file my virus software kicks in and says that a malicious script has been detected. Anyone else having this problem? Can someone look at the document and copy and paste the part about DOC bands into an email for me? Thanks for the help. Gail For more plagio info Quote Link to comment Share on other sites More sharing options...
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