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SuperPole™ Bariatric with SuperBar™

Healthcraft Products Inc. · Model SPB-HD · UDI-DI 00689281015028

FMR

510(k) clearances

132

Adverse events (2 deaths)

Recalls

248

Facilities

Description

The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole (floor to ceiling safety pole). The horizontal bar can be lifted, pivoted and lowered to the next locking position around the SuperPole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves (every 45 degrees) to provide a mechanism strong enough for the SuperBar to support the user. It is important to set proper height and orientation of the SuperBar to optimize the user’s range of motion. Floor To Ceiling Height 93-99" / 2362-2515mm Max User Weight450lbs / 205kgs

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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.