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Posted On: 09/29/2022 1:00:18 PM
Post# of 8390
This was actually a QARA Pre Submission
"QARA FDA 510k FDA Pre Submission process is used by the applicant to obtain feedback from FDA before actual submission for the 510 (k) clearance."
The Pre Submission process gives FDA feedback on what they want for a successful 510k submission.
I would also speculate that BIEL is asking the FDA if a new 510k Clearance is required for the RecoveryRX XTRA since the electronics and function have not changed, just the shape of the antenna.
https://www.i3cglobal.com/fda-premarket-submi...0clearance.
"QARA FDA 510k FDA Pre Submission process is used by the applicant to obtain feedback from FDA before actual submission for the 510 (k) clearance."
The Pre Submission process gives FDA feedback on what they want for a successful 510k submission.
I would also speculate that BIEL is asking the FDA if a new 510k Clearance is required for the RecoveryRX XTRA since the electronics and function have not changed, just the shape of the antenna.
https://www.i3cglobal.com/fda-premarket-submi...0clearance.
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