(120 days)
The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 months with gastroesophageal reflux to rest comfortably in a semi-upright position; it is used for sleeping and playtime in supine, prone, and side-lying positions.
Device Name: RES-Q Infant Wedge & Sling
Classification/Common Name: Holder, Infant Positioner
Code FRP, CFR 880.5680
Class 1
The provided text is a 510(k) summary for the RES-Q Infant Wedge & Sling, which is an infant positioner. It does not contain information about a study with acceptance criteria, reported device performance, or details typically associated with the evaluation of AI/ML devices or diagnostic tools.
The document states: "FDA has not established special controls or performance standards for this device."
Therefore, I cannot provide the requested information from the given text as it is not present. This device is a Class I medical device, which typically has lower regulatory scrutiny and does not require extensive performance studies and acceptance criteria as would be expected for a diagnostic or AI-powered device.
§ 880.5680 Pediatric position holder.
(a)
Identification. A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.(b)
Classification. Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.