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Address: #505, 31st Street, Newport Beach, California 92663, USA
www.orthomerica.com |
Send Inquiry |
Phone: +1-(949)-723-4500
FDA Registration: 1058152 Year Established: 1989
Annual Revenues: USD 10-25 Million
Employee Count: ~90
Quality: ISO 9001, CE Certified
Products: Acetabular Liners, Hip Orthoses, Pediatric Orthoses, Prefabricated Hip Orthoses, Bilateral Hip Orthoses, Unilateral Hip Orthoses, ...
Orthomerica Products, Inc. manufactures and markets prefabricated, semi-custom & custom orthoses. We are an ISO 9001, CE MARK certified company. We offer products like hip orthoses, low extremity orth
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Address: 20 Ledin Drive, Avon, Massachusetts 02322, USA
www.bostonbrace.com |
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Phone: +1-(508)-588-6060, (800)-262-2235
FDA Registration: 3001967835 Year Established: 1952
Annual Revenues: < USD 1 Million
Employee Count: ~40
Products: Shoulder Braces, Hip Orthoses, Lumbosacral Braces, Straps, Slings & Immobilizers, Wrist/Arm/Shoulder Braces & Supports, Prefabricated Hip Orthoses, ...
Boston Brace International, Inc. designs and manufactures medical & sports bracing products for prevention, rehabilitation & correction. We offer products such as scoliosis, boston band, dynamic movem
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Address: 2480 West 82nd Street, No. 8, Bay 1a, Hialeah, Florida 33016, USA
www.biosculptor.com |
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Phone: +1-(305)-5565815
FDA Registration: 1000560772
Products: CT Scanners, CT Scan, Dual Laser Scanner, A-Scan Biometers, Biometric Analyzer A-Scan, Cranial Orthosis (FDA Code:
MVA), ...
Biosculptor Corporation offers Bioscanner™ tools, AFO tools, Bioshape software and Biomill™. Our BioScanner™ is able to image negative and positive models allowing to use the clinica
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FDA Code / Regulation: OAN / 882.5970 A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Classification. Class II (special controls) (prescription use in accordance with 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).