21 CFR 870.2705 — Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2705
Identification
The Dream Sock is an infant pulse rate and oxygen saturation monitor for over-the-counter (OTC) use. It uses photoplethysmography (PPG) to measure pulse rate (PR) and oxygen saturation (SpO2) in infants 1 to 18 months of age and 6 to 30 lbs. The device analyzes PPG data to identify when PR or SpO2 moves outside a preset range, provides notifications to the caregiver, and displays PR, SpO2, and trend data. It is intended for use in a home environment to supplement caregiver decision-making and is not intended to replace traditional monitoring, diagnosis, or treatment, nor is it for use with infants diagnosed with cardiovascular or respiratory conditions.
Classification Rationale
Class II (special controls). The device is classified as Class II under 21 CFR 870.2705, subject to special controls in addition to general controls to mitigate risks such as poor signal quality, misinterpretation of output, adverse tissue reaction, and false positive/negative results.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | 2 | 2 |
Special Controls
QYU — Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
In combination with the general controls of the FD&C Act, the infant pulse rate and oxygen saturation monitor for over-the-counter use is subject to the following special controls:
De Novo Order DEN220091
