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Shenzhen WAP-health Technology Co.Ltd · Model Fast Response Kit · UDI-DI 06975033060076

OHO
0
510(k) clearances
5
Adverse events
1
Recalls
237
Facilities

Description

Fast Response Kit Brand Name: Custom-branded with “American AED” or “One Beat Medical.”

Recalls

DateFirmReason
2026-07-07INTEGRATED MEDCRAFT LLCDevices could potentially contain an occluded or partially occluded Guedel Airway tip.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.