Medical devices; physical medicine devices; classification of the powered exoskeleton. Final order.
Fed Regist
; 80(36): 9600-3, 2014 Feb 24.
Article
en En
| MEDLINE
| ID: mdl-25735053
: The Food and Drug Administration (FDA) is classifying the powered exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Buscar en Google
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Aparatos Ortopédicos
/
Medicina Física y Rehabilitación
/
Aprobación de Recursos
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Fed Regist
Año:
2014
Tipo del documento:
Article
Pais de publicación:
Estados Unidos