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Heart & blood pressure

Withings BPM Connect FDA Record: K223374

What FDA’s K223374 summary says about the WPM05 BPM Connect, its intended use, arm range and connectivity features.

Quick answer

The FDA K223374 summary identifies the WPM05 model as BPM Connect. It describes a digital adult blood-pressure and pulse monitor and lists its stated arm range and connectivity.

What the FDA summary identifies

FDA summary field WPM05 (BPM Connect) details
510(k) number K223374
Device model WPM05, identified as BPM Connect
Intended function Measure blood pressure and pulse rate
Population and arm circumference Adults, 9 to 17 inches (22 to 42 cm)
Use environment Indoor
Listed connectivity Bluetooth and Wi-Fi synchronization with the Withings application and server

The FDA summary is for a device family submitted by Guangdong Transtek Medical Electronics. It names WPM05 and WPM06 in the same record, so match the exact model before relying on any field.

Record-matching checklist

  1. Check the label for model WPM05.
  2. Compare the maker’s current product name and instructions with the FDA summary.
  3. Read the full summary for its intended use and stated limits.
  4. Do not use a regulatory record to interpret an individual measurement.
  5. Discuss blood-pressure readings or care decisions with your doctor.

See how to choose a home blood-pressure monitor and how to share health data with your doctor. Browse blood-pressure monitors.

Sources

Common questions

Does K223374 name BPM Connect?

The FDA 510(k) summary lists WPM05 (BPM Connect) among the subject device models.

What does the summary say it measures?

It describes an upper-arm digital monitor intended to measure blood pressure and pulse rate in adults.

Does the FDA record tell me how to interpret a reading?

No. The entry describes a device and regulatory submission. Ask your doctor about readings or health questions.