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Zynex Pro Hybrid LSO 637

Manamed, Inc. · Model 123237 · UDI-DI 00810113683058

IPY
10
510(k) clearances
10
Adverse events
1
Recalls
189
Facilities

Description

The Zynex Pro Hybrid LSO 637 is a universal sacral-lumar orthosis designed with our patent pending chord compression system with center hub compression technology. It is designed to provide a rigid, comfortable, and quick fitting solution for every patient. Ice pack included. Easy application, universal size Removable ice pack Lightweight, latex free breathable material Double pulley system

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

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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.