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Raz

Raz Design Inc · Model Raz-AT600 · UDI-DI 00628758003601

INN
10
510(k) clearances
590
Adverse events (10 deaths)
23
Recalls
137
Facilities

Description

Individually configured, mobile and stationary commode chairs for use during showering and toileting. The Raz-AT600 is a Heavy Duty Mobile Shower Commode Chair (up to 600 lb weight capacity) with stainless steel frame and components, four locking 6” (150mm) casters and commode pan. The specially engineered, Weight Assist Spring System (WASS) is available in two weight ranges and is adjustable to accommodate the user’s weight and Center of Mass (CoM) for tilt operation with minimal effort by the attendant. The AT600 has 25o tilt range to assist with pressure reduction and redistribution, postural support, comfort, and transfers.

Recalls

DateFirmReason
2026-01-05Raz Design IncDue to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
2022-11-30Altimate Medical, Inc.Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.
2021-12-08R82 A/SThe chrome surface of the push brace can crack during use, potentially cutting the user.
2021-05-12Stryker Medical Division of Stryker CorporationMedical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2015-04-02Winco Mfg., LLCShipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02Winco Mfg., LLCShipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02Winco Mfg., LLCShipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02Winco Mfg., LLCShipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02Winco Mfg., LLCShipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02Winco Mfg., LLCShipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

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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.