SUREPULSE MEDICAL LIMITED
1 recall(s) on record — most severe on record: Class III.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- OximeterProduct code DQA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700
Recalls & enforcement
- Class IIIOngoing2023-01-20Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA inspections (1)
- OAI2024-08-01Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “SUREPULSE MEDICAL LIMITED (FEI 3018685978) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3018685978-surepulse-medical-limited/
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