Interesting items re Extra Strength RecoveryRx FDA
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Posted On: 08/21/2022 5:51:19 PM
Interesting items re Extra Strength RecoveryRx FDA Clearance
IMO, his is going to be an important product for BIEL. People are inherently impatient especially when pain is involved. If the ES RecoveryRx can relieve pain 30% (or more) faster than RecoveryRx we have a winner. It will also be able to penetrate deeper into the body addressing issues that the standard RecoveryRx can't reach.
The 2019 RecoveryRx FDA 510k for Post-Op Pain uses the ActiBand, original name for ActiPatch, as one of its Predicate devices.
In 2002, when the ActiBand was FDA Cleared, Summary documents were not posted showing the technical aspects of the medical device.
For the 2019 510k use of ActiBand as a Predicate some technical information is listed. This 510k states that ActiBand was a 6 volt device powered by 2 each 3 volt CR2032 batteries. This is the same configuration that the Sofpulse uses.
So, a larger higher voltage power source, RecoveryRx/ActiPatch both use 1 each 3 volt battery, should not raise any red flags with the FDA for our Extra Strength RecoveryRx 510k Clearance.
The Sofpulse was the second Predicate used in the 2019 Clearance. Sofpulse was FDA Cleared in 2008 with no Human Clinical Trials. They used Bench Testing and Animal Models to validate performance.
https://www.accessdata.fda.gov/scripts/cdrh/c...ID=K190251
IMO, his is going to be an important product for BIEL. People are inherently impatient especially when pain is involved. If the ES RecoveryRx can relieve pain 30% (or more) faster than RecoveryRx we have a winner. It will also be able to penetrate deeper into the body addressing issues that the standard RecoveryRx can't reach.
The 2019 RecoveryRx FDA 510k for Post-Op Pain uses the ActiBand, original name for ActiPatch, as one of its Predicate devices.
In 2002, when the ActiBand was FDA Cleared, Summary documents were not posted showing the technical aspects of the medical device.
For the 2019 510k use of ActiBand as a Predicate some technical information is listed. This 510k states that ActiBand was a 6 volt device powered by 2 each 3 volt CR2032 batteries. This is the same configuration that the Sofpulse uses.
So, a larger higher voltage power source, RecoveryRx/ActiPatch both use 1 each 3 volt battery, should not raise any red flags with the FDA for our Extra Strength RecoveryRx 510k Clearance.
The Sofpulse was the second Predicate used in the 2019 Clearance. Sofpulse was FDA Cleared in 2008 with no Human Clinical Trials. They used Bench Testing and Animal Models to validate performance.
https://www.accessdata.fda.gov/scripts/cdrh/c...ID=K190251
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