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reshamn replied to the topic Verification Protocol in the forum Introduction to Design Controls 7 years, 5 months ago
Multiligamentous Ankle Supports (L1906)
A multiligamentous ankle support provides control of the ankle joint between the medial and lateral malleoli while allowing for dorsiflexion and plantar flexion.
Medicare announced an additional verification for the ankle supports to
1. Include a rigid stirrup and foot plate which provides functional tracking of the ankle with hind-foot and mid-foot stability during ambulation.
2. Include an ankle gauntlet, prefabricated, fitting and adjustment.