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P-POD Plagiocephaly Helmet is a Class II cranial orthosis intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads. The P-POD helmet is similar to the predicate devices in such that it is an
orthosis designed for each patient from a cast of the infant's head. Each orthosis is composed on an outer shell with a layer of foam and a side strap for securing the orthosis. Additionally, the helmet has a top vent and side opening as typically seen with the predicates. Optimum fit and alignment is insured and monitored by the clinical practitioner.
PPOD Orthotics Inc.
DD-1930
In Commercial Distribution
- 00196852667895 ()
DD-1930
- Cranial orthosis
The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use 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- and brachycephalic-shaped heads.
DANMAR PRODUCTS INC
9841
In Commercial Distribution
- 00862948000302 ()
- Cranial orthosis
The kinderBAND™ cranial remolding orthosis is a custom made orthotic device available by prescription only. It is used to treat infants between 3 and 18 months of age for asymmetrical head shapes such as positional plagiocephaly, brachycephaly and scaphocephaly.
BIOSCULPTOR CORPORATION
CL-4000
In Commercial Distribution
- 00863457000302 ()
CL-4000
- Cranial orthosis
Boston Band custom cranial remolding orthosis
Boston Brace International, Inc.
BB1
In Commercial Distribution
- 00860010708101 ()
- Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/2in1/Bi-Valve Opening
In Commercial Distribution
- 00860013898076 ()
- Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/2in1/One-Side Opening
In Commercial Distribution
- 00860013898069 ()
- Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/Bi-Valve Opening
In Commercial Distribution
- 00860013898052 ()
- Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/One-Side Opening
In Commercial Distribution
- 00860013898045 ()
- Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/2in1/Bi-Valve Opening
In Commercial Distribution
- 00860013898038 ()
- Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/2in1/One-Side Opening
In Commercial Distribution
- 00860013898021 ()
- Cranial orthosis