Withings Sleep Analyzer
Strong Clinical Evidence
FDA 510(k) Cleared
Home Sleep Tests

Withings Sleep Analyzer

by Withings Model: WSM02 / Sleep Rx (K231667)

$199.95
94/100
Clinical Score
HSA/FSA: Usually Eligible

Key Features

Contactless under-the-mattress mat requires no wearable components. [cite: 47, 85, 1149]
Provides a 'Withings Index' used as a diagnostic aid for Obstructive Sleep Apnea. [cite: 46, 54, 68]
Integrated microphone for specialized snoring duration and intensity analysis. [cite: 130, 131, 1154]
IFTTT integration for home automation (e.g., controlling lights/thermostat based on bed exit). [cite: 1192, 1193]

Device Overview

The Withings Sleep Analyzer is a contactless, pneumatic-based mat placed under the mattress to provide lab-precise sleep metrics. [cite: 47, 1149, 1150] It measures sleep quality, resting heart rate, and snoring while functioning as a clinical aid for diagnosing obstructive sleep apnea (OSA) in adults. [cite: 46, 54, 1151]

Technical Specifications

Model Number WSM02 / Sleep Rx (K231667)
Manufacturer Withings
Connectivity
Bluetooth Wifi
Category Home Sleep Tests
Channels Monitored (airflow/effort/SpO2/position) Breathing (sound/pressure variations), Heart Rate, and Movement (Actigraphy). [cite: 48, 51, 102, 1211]
AHI Detection Range Validated against PSG for AHI thresholds of ≥15 and ≥30 events/hour. [cite: 140, 145]
Recording Duration (nights) Continuous tracking while plugged into a power source. [cite: 1229, 1231]
Sensor Types Advanced pneumatic bladder with pressure sensor and embedded microphone. [cite: 87, 1154, 1231]
Data Format & Export Withings Health Mate app (iOS/Android), PDF clinician reports, and Apple Health integration. [cite: 53, 117, 1209, 1233]
FDA Classification Class II, Regulation 21 CFR 868.2375 (Breathing Frequency Monitor). [cite: 2, 45, 137]
Board-Certified Interpretation Included No (Results are intended to assist healthcare professionals in determining further diagnosis). [cite: 50, 57]
Prescription Requirement No (Available Over-The-Counter for general sleep tracking; 'Sleep Rx' version is prescription only). [cite: 39, 1083]

Cost & Coverage Analysis

Pricing Breakdown

Device Price $200

HSA / FSA Eligibility

Usually Eligible

Eligibility may vary by provider and plan. Check with your HSA/FSA administrator for specific details.

Clinical Review

Evidence-based evaluation by medical professionals

"The premier non-wearable solution for long-term sleep apnea screening and cardiac monitoring, combining medical-grade accuracy with zero user burden."
Strong Clinical Evidence Highly Recommended
94
Score

The Withings Sleep Analyzer (marketed as Sleep Rx in the U.S. for clinical applications) represents a shift in home sleep diagnostics by eliminating the need for wearables. Placed discreetly under the mattress, it utilizes advanced pneumatic sensors to measure heart activity via ballistocardiography (BCG), respiratory rate, and body movement, while an embedded microphone identifies snoring and breathing cessation events. Clinical validation studies, including those conducted at Hôpital Béclère, demonstrated that its 'Withings Index' matches gold-standard polysomnography (PSG) with 88% sensitivity and 88.6% specificity for moderate-to-severe sleep apnea (AHI ≥ 15). The device is particularly effective for longitudinal monitoring, as its passive nature ensures high patient adherence over months rather than just a single night. While it lacks the direct brain-wave tracking of EEG-based devices, its ability to provide shareable clinical PDF reports and integrate with smart home environments through IFTTT makes it an exceptionally versatile tool for both patients and clinicians.

Comparative Performance

Highest-rated device in Home Sleep Tests category

1
Withings Sleep Analyzer

Withings Sleep Analyzer

Withings

Current Top Rated
94 /100
Viewing
2
Sunrise Home Sleep Test

Sunrise Home Sleep Test

Sunrise SA

3
NightOwl Home Sleep Apnea Test

NightOwl Home Sleep Apnea Test

ResMed

Highest Clinical Rating

This device achieved the highest overall score among 25 clinically evaluated home sleep tests devices, demonstrating superior performance across key testing protocols and real-world validation metrics.

Where to Buy

Verified retailers and current pricing

Withings Official Store

Price: $199.95
3-5 business days

FSA/HSA eligible. [cite: 1230]

Shop Now

Amazon

Price: $199.95
Next day Prime delivery

Standard consumer version; not the Sleep Rx model.

Shop Now

Best Buy

Price: $199.95
Same day pickup

Requires Wi-Fi connection for initial setup and data sync.

Shop Now

Important Information

  • • Prices and availability subject to change
  • • Some devices may require a prescription
  • • HSA / FSA eligibility: Usually Eligible
  • • Purchase from authorized retailers for warranty protection
Visit Manufacturer Website