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The Clarren Helmet is a patient specific cranial orthosis that applies passive 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. The Clarren Helmet is made with an outer polypropylene plastic shell with a Plastizote inner liner and a chinstrap to help hold the helmet in place.
ORTHOMERICA PRODUCTS, INC.
703.05A
In Commercial Distribution
- B15170305A0 ()
703.05A
- Cranial orthosis
The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARlight® is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. It utilizes a side opening design and is held in place by a Velcro® strap across the side opening.
ORTHOMERICA PRODUCTS, INC.
703.03PA
In Commercial Distribution
- B15170303PA0 ()
703.03PA
- Cranial orthosis
The STARlight® is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARlight® is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. It utilizes a side opening design and is held in place by a Velcro® strap across the side opening.
ORTHOMERICA PRODUCTS, INC.
703.03A
In Commercial Distribution
- B15170303A0 ()
703.03A
- Cranial orthosis
The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARlight® Bi-Valve is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. It utilizes an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
703.01PA
In Commercial Distribution
- B15170301PA0 ()
703.01PA
- Cranial orthosis
The STARlight® Bi-Valve is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The STARlight® Bi-Valve is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. It utilizes an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
703.01A
In Commercial Distribution
- B15170301A0 ()
703.01A
- Cranial orthosis
Eye-Safe Laser Data Acquisition System that collects 3-D infant’s head shape data which is used for the fabrication of cranial orthoses.
Vorum Research Corporation
Series B
In Commercial Distribution
- B590507012000 ()
50-7012-00
- Cranial orthosis
No Description
CRANIAL TECHNOLOGIES, INC.
CRANIALHELMET
In Commercial Distribution
- B288CRANIALHELMET0 ()
CRANIALHELMET
- Cranial orthosis
No Description
Aktina Corp.
57-905
In Commercial Distribution
- B365579050 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
57-901
In Commercial Distribution
- B365579010 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
56-000-SL
In Commercial Distribution
- B36556000SL0 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized