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Tuesday, January 23, 2024 3:09:46 PM
If Ilfeld gets a positive clinical outcome on the lower powered device than so much the better.
Just because there is a new improved version of the device doesn’t preclude usage of the existing device.
Furthermore, RecoveryRXExtra is only a modification of the existing Actipatch which meets the FDA criteria for a substantially equivalent device under the authorization granted in 2019.
This is why any further FDA approval for marketing the RecoveryRXExtra if needed would be expedited imo.
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf
BIEL
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