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ManaEZ Night Splint, Plantar Fasciitis, Medium

Manamed, Inc. · Model EZSPNT01-M · UDI-DI 00810113683133

ITW
1
510(k) clearances
76
Adverse events
3
Recalls
461
Facilities

Description

Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight Achilles, Achilles Tendonitis, and conditions where dorsiflexing the foot is part of the rehabilitation protocol. Easy-to-apply universal left/right design available in 3 sizes.

Recalls

DateFirmReason
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-04-13United Surgical AssociatesThe product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.