Guest guest Posted October 3, 2002 Report Share Posted October 3, 2002 Hi Amy - welcome to the group!! Wow, it sounds like you have been on quite a rollercoaster ride with all of this. That is really good news though that it ends up not being cranio and is plagio., I'm sure your family is relieved about not needing surgery! Too bad they misinformed you though, I can imagine the worries your family has been thru! We just had a recent post about the Ballert Helmet - was that from you? I had never heard of it before that post, this was just posted a wk or 2 ago. If it wasn't your post, maybe you could talk with this other parent to share experiences with. Adam is at a great younger age to begin his treatment. He should see fast & excellent results. Most bands should be fitted to the baby's head not much later than 2 wks after the casting has been done. Is your ins. covering treatment? (hope so!). Bring someone along to the casting with you, the casting is fast & painless, but it usually does tick the baby off! They don't like being held down or having their eyes covered up. You can bring along a loud toy or favorite music to try to distract Adam with during the cast. Too bad he doesn't take a pacifier for this - my daughter didn't either, she's a thumb sucker, but didn't suck her thumb while she was being cast, she was too mad! You are right, the casting will be much harder on you & your family than it will on Adam - he'll quickly recover after the cast & go about his happy little life! Good luck - please let us know how it goes. Welcome again to our group - be sure you keep us posted on his progress. Happy to have you. Debbie Abby's mom DOCGrad MI > > Are there basically 2 types,the STAR & the DOC? > > Kelli, > > The STARbands and DOCbands are actually two examples of an active > design for cranial orthosis. Basically, when getting a moulding > device, you have two choices....either a passive design (your locally > made helmets) or an active design. The STARbands and DOCbands do > seem to be more common, but there are quite a few FDA approved > devices out there. As good timing would have it, I just received an > email from Orthomerica with a list of different FDA approved designs > which I'll paste below. I do just want to reitterate though, that > success with any device is dependant upon an expereienced and > knowledgable ortho! > > Niki > Here's that list for you: > > > 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 > > > > > 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 > > > > > K964992 > DOC Band > Cranial Technologies, Inc. > 1331 North 7th St., #170 > Phoenix, AZ 85006 > 05/29/1998 > > > > > 1 http://www.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm > > > > > > Quote Link to comment Share on other sites More sharing options...
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