(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.
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JUN – 5 2009
510(k) Summary
. "
| Submitter's Information: | CR Enterprises, LLC |
|---|---|
| 4701 Augusta Dr | |
| Frisco TX 75034 | |
| Contact: Craig A. Troop, M.D. | |
| Phone: 972-625-5177 | |
| December 15, 2008 | |
| Device/Classification Name | Device Name: RES-Q Infant Wedge & Sling |
| Classification/Common Name: Holder, Infant Positioner | |
| Code FRP, CFR 880.5680 | |
| Class | Class 1 |
| Predicate Devices | Pedicraft Reflux Wedge - 510(k) #K905629Tucker Sling - 510(k) #K932636 |
| Intended Use | The RES-Q Infant Wedge & Sling is designed to allow babies 0-12months with gastro-esophageal reflux to rest comfortably in asemi-upright position; it is used for sleeping and playtime insupine, prone, and side-lying positions. |
| Performance Summary | FDA has not established special controls or performancestandards for this device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are written around the top of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Craig A. Troop, M.D. Manager C.R. Enterprises, LLC 4701 Augusta Drive Frisco, Texas 75034
JUN = 5 2009
Re: K090284
Trade/Device Name: RES-Q Infant Wedge and Sling Regulation Number: 21 CFR 880.5680 Regulation Name: Holder, Infant Positioner Regulatory Class: I Product Code: FRP Dated: May 20, 2009 Received: June 2, 2009
Dear Dr. Troop:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Troop
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely-vours-
Anthony D. Minter for
SHERRI DAVENPORT, R.R.C., M.A.
Susan Runner, D.D.S., MA Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known): K090284
Device Name: RES-Q Infant Wedge & Sling
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
443 Juri- For (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KD90284
§ 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.