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Posted On: 07/15/2019 11:43:36 AM
Post# of 8577
RecoveryRx Summary Document now added to FDA 510k Database
Details of the Clearance now available
Dear Dr. Koneru:
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.
Conclusion: The non-clinical data and clinical data demonstrate that the RecoveryRx is at least as safe and effective as the predicate devices and can be used as a prescription device for the adjunctive treatment of postoperative pain.
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf
Details of the Clearance now available
Dear Dr. Koneru:
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.
Conclusion: The non-clinical data and clinical data demonstrate that the RecoveryRx is at least as safe and effective as the predicate devices and can be used as a prescription device for the adjunctive treatment of postoperative pain.
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf
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