Re: A question about helmets?

[Guest guest]

Amy-

Welcome to the group!

I think we all have felt the same as you at one point. I was told

to lay my son on his right side and did constantly, so I totally

relate to feelings of guilt.

I can't blame you for being angry with the radiologist. NOt only

did you get freaked out about the cranio scare, you lost a month of

repositioning! Hopefully she can learn from her mistake.

My son doesn't take a pacifier either. Remember that it'll be over

in 10 minutes no matter how upset he gets! If I had to do it all

over again, I'd bring some white noise. My son responds to that

very well.

We have had 2 other members' babies get casted at Ballert this week,

Taryn and Ray. I guess things do happen in 3s!

Adam should adjust easily to his helmet. When you get it and see

how well he will do, you will feel so much more at ease.

, also 30

Dane's mom DOC Grad

> > 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

>

>

>

>

>

>