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510(k) Data Aggregation
K Number
K202499Device Name
Diamond Digital Sleep Orthotic (DDSO)
Manufacturer
Diamond Orthotic Laboratory
Date Cleared
2020-09-03
(3 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Diamond **Orthotic **Laboratory
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diamond Digital Sleep Orthotic (DDSO) is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Diamond Digital Sleep Orthotic (DDSO) is a removable intraoral device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward, (protrusive) position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space and decrease air turbulence, therefore improving their ability to exchange air during sleep.
The DDSO is a patient-matched prescription medical device, indicated for use during sleep to treat patients who snore and/or have mild to moderate obstructive sleep apnea. The design consists of two splints that fit independently over the upper and lower teeth and engage by means of an adjustable mechanism. This mechanism enables the practitioner to set the amount of mandibularadvancement at the time of fitting the device.
The amount of titration (mandibular protrusion) ranges from in 1.0 mm increments.
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K Number
K111247Device Name
CRANIAL REMOLDING ORTHOSIS
Manufacturer
ORTHOTIC CARE SERVICES, LLP
Date Cleared
2011-08-15
(104 days)
Product Code
MVA
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
**ORTHOTIC **CARE SERVICES, LLP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads, by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.
Device Description
The Cranial Remolding Orthosis is prescribed for use on infants between 3-18 months with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic, scaphocephalic, and brachycephalic-shaped heads by applying pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. The Cranial Remolding Orthosis is also prescribed for use following minimally invasive surgery for infants between 3-18 months with craniosynostosis who still need moderate to severe correction of plagiocephali-shaped, brachycephalic-shaped, and/or scaphocephalic-shaped heads.
The device allows for growth of the flattened areas of the infant's skull into the voids within the shell and foam lining. This combination of total contact and relief allows for significant correction of the asymmetrical head shape; thereby giving the infant's skull a more symmetrical and/or proportioned shape.
The Cranial Remolding Orthosis is fabricated from a 3/16" co-polymer base plastic shell with a ½" foam interface liner. The type of material used on the foam interface liner is Pelite polvethylene foam, Plastazote, or Aliplast foam spacer fills a ½" side opening, opposite the deficit, utilizing the same material as the corresponding foam liner. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above and around the ears. The posterior inferior is trimmed distally to capture the occiput. A hook and loop closure (also referred to as Velcro within the industry) is attached on the side of the deficit, bridging over the side opening, keeping the device securely in place.
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K Number
K063395Device Name
O&P BIVALVE CRANIAL MOLDING HELMET
Manufacturer
ORTHOTIC & PROSTHETIC LAB, INC.
Date Cleared
2006-12-22
(43 days)
Product Code
MVA
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
**ORTHOTIC **& PROSTHETIC LAB, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The O&P Bivalve Cranial Molding Helmet 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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.
Device Description
O&P Bivalve Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round creating a void. As the child's head grows, the skull is slowly reshaped and rounded by growing into the open voids created in the helmet for this purpose. The finished helmet has a foam-lined interior and has rigid plastic exterior. The helmet is bivalve with the anterior section overlapping the posterior section. The helmet is secured by means of a rivet on one side and an elasticized Velcro closure on the opposite side.
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K Number
K021594Device Name
COPC BAND
Manufacturer
CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC
Date Cleared
2003-11-13
(547 days)
Product Code
MVA
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
CENTER FOR **ORTHOTIC **AND PROSTHETIC CARE,LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COPC Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants initiating treatment from three to 14 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.
Device Description
The COPC Band is a cranial orthosis used to treat abnormally shaped craniums in infants three to 14 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened areas of the skull into the created spaces. The COPC Band is only available through a prescription issued by a physician. The orthosis is custom designed for each patient from a modified model and measurements of the infant's head. The mold is prepared for fabrication using advanced plaster modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, an inner lining of hypoallergenic foam, and a strap for securing Optimum fit and alignment is insured and monitored by the clinical the orthosis. practitioner.
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K Number
K021221Device Name
O&P CRANICAL MOLDING HELMET
Manufacturer
ORTHOTIC & PROSTHETIC LAB, INC.
Date Cleared
2002-07-01
(75 days)
Product Code
MVA
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
**ORTHOTIC **& PROSTHETIC LAB, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.
Device Description
O&P Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round. The finished helmet has a hard middle layer with a padded inner and outer laver. There are ventilation holes in the top of the helmet is held in place with a chinstrap.
O&P Cranial Molding Helmets work in two ways. The first way is that the helmet fits close to the head where the head sticks out, and loosely over the flattened area. The skull will grow into the loose area of the helmet, allowing the flattened parts of the head to "catch up" with the prominent areas. This type of helmet is known as a "passive" or "Clarren style" helmet. The second way the helmet is effective is by providing a rounded surface for the infant's head to lie on, removing the worry about proper positioning.
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K Number
K010273Device Name
CRANIAL MOLDING ORTHOSIS
Manufacturer
ORTHOTIC SOLUTIONS, INC.
Date Cleared
2001-04-25
(86 days)
Product Code
MVA
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
**ORTHOTIC **SOLUTIONS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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