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Orthosis, Cranial

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5970
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5970 Cranial orthosis

§ 882.5970 Cranial orthosis.

(a) Identification. 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.

(b) 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)).

[63 FR 40651, July 30, 1998]

Orthosis, Cranial

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5970
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.5970 Cranial orthosis

§ 882.5970 Cranial orthosis.

(a) Identification. 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.

(b) 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)).

[63 FR 40651, July 30, 1998]