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Spex Limited

SPEX LIMITED · Model PROMO-ATPKIT-18 · UDI-DI 09420051798649

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0
510(k) clearances
5
Adverse events (1 deaths)
1
Recalls
49
Facilities

Description

Spex PROMO-ATPKIT-18 A standardised Assistive Technology Professional Accessory Kit - Adult (18") Includes 1275-0044-000 Spex Extended Lateral Head Support Head Support pad (000 Black) 1266-3046-400 Axial Biangular Lateral Pad Size 6, with 12mm Pressure Reduction padding, Standard cover 1259-2400-100 Spex Back Support Quad Mount Hardware 1266-2501-100 Axial Biangular Lateral Bracket (for use with Axial Biangular Lateral Pad) 1266-2301-100 Spex Swing-Away Lateral Bracket, Axial; includes protective neoprene sleeve 1274-1282-000 Stylo 260 Head Support Fixed Extended Mechanism 1250-3955-000 TSS Lite Contouring Kit 1266-3012-400 Narrow Straight lateral pad with standard cover, size 2; 95mm high x 180mm deep 1266-3012-800 Narrow Straight lateral pad with Comfy-cover, size 2; 95mm high x 180mm deep. 1266-3046-400 Axial Biangular Lateral Pad Size 6, with 12mm Pressure Reduction padding, Standard cover 1275-0043-000 Spex Standard Lateral Head Support Head Support pad (000 Black) 1400-6692-000 Spex Shoulder Strap Guides/Retainer, Pair

Recalls

DateFirmReason
2008-11-06Snug Seat IncBreakage in the welds was discovered in a section of the chair frame.

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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.