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Nah. Admissible does not equal approved. They didn't bother to review any of the testing because they were going to reject the 510k on the basis of the new "criteria" under the new classification.
They will review all the tests in conjunction with each other after the new 510k submission.
From PR
“This, along with a guarantee that all current test results are admissible”
Would seem to suggest FDA were happy with tests.
It doesn't say the tests were approved it says they can submit them to review along with the rounds of additional testing they will have to do.
I added a bunch more this morning.
im going to keep it on my watchlist but at this point we're looking at another 6-12 months for a new submission and fda feedback.....SOB!.....goodluck!
Agree, if device had been refused on its own merits then I can understand the drop in price, but PR clearly states nothing to do with device.
I would also add that PR seemed to suggest that test that had to be redone by company was accepted by FDA, which is good news.
right, like the FDA neglected to acknowledge this during the other 510k submissions and then waited for this one and went "aha" we need to address this now too. idk what internal parameters changed but seems like the FDA just fucked them and making them redo this again when they could have killed two birds with one stone before....kinda shameful on the FDA
It does talk about cavity, so I see why it could, but ridiculous at such a late stage to reclassify it.
yea i mean FDA is boss so they literally call the shots however they want. really confusing to see a mask being submitted as an implantable device? no part of it is being implanted subcutaneously. would have rather heard from the FDA than Remsleep about what happened
Not machine, you mean the mask.
Shocked how easy it is for the FDA just to change submission as it sees fit. I think the recall fiasco has a lot to do with what’s going on in the CPAP device market.
so straange the FDA regarding a CPAP machine as an implantable device
read the posts below us from earlier today.....FDA correspondence is to pull the current 510k and resubmit a new application under an implantable device....back to the drawing board and delays but still the same fundamentals and company
FDA just gave some great opportunity to add with sudden change of criteria which is forcing company to submit a new 510k application as suddenly it’s an implantable device.
yea that'll be game set and match for now, back to the drawing board and back to baseline to draft this new 510k. no clue how they define a CPAP machine as an implantable device and recommend they go down that route? i work for an implantable monitoring device company for cardiology, similar to a pacemaker, and that is the 510k process we used. odd direction from the FDA. either way.....lost a little here...using the rest towards TCRI which could be massive.....
RMSL withdrawing 510k...will hit the skids hard:
https://www.otcmarkets.com/stock/RMSL/news/story?e&id=2233548
Tampa, FL , June 06, 2022 (GLOBE NEWSWIRE) -- RemSleep Holdings Inc (OTC PINK: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive sleep apnea patients, today provides a corporate update and letter from CEO Tom Wood .
Dear Shareholders,
On Friday the 27th of May, we were informed by the FDA after months of waiting, the DeltaWave will be reclassified under 510K review as an implantable device. Consequently, additional testing is now required under this new classification. Management was advised to withdraw the current 510K application and resubmit after the new testing parameters have been satisfied. RemSleep is presently engaging the professionals perfectly suited to perform all new testing requirements and will fast-track this new requirement to submit the new 510K without delay. RemSleep has written acknowledgment from the FDA reviewer that all the testing submitted to date will be applicable to the new 510K submission. We worked diligently to comply with all known requirements to ensure that the current submission was accurately prepared, but due to the recent CPAP-related recalls, and other various complaints, DeltaWave’s 510K status has been an evolving, fast-moving target within the FDA.
Regardless, RemSleep takes full responsibility for all issues. Frankly, RemSleep is in a stronger position because in previous submissions we were not provided definitive guidelines. The last correspondence we received from the reviewer was accompanied with information providing a definitive guideline of requirements that we are now aware must be met to satisfy this new classification. This, along with a guarantee that all current test results are admissible, leaves us optimistic, since we are now proceeding without the previous uncertainties. Although disheartened by this setback, we expect to get this new 510K submission approved in a timely manner, and subsequent 510K submissions should go through the validation process much easier. Simultaneously we are planning to soon submit the next 510K on our next-generation Nasal Pillows interface, which we believe will be the new standard of world-class.
Our OTCQB application status is in the final stages of being completed by our securities attorney.
We will continue to update our shareholders. We understand your frustrations, and thank you for your patience during this time
It's possible hear from the FDA on Monday.Possible not probable.But within the next couple weeks fo sho!You gotta like management's persistence here.
You’re wrong again! You figure it out yourself like me and others have! Lol
Please...
The pressure is what holds the airway open or reopens it, and there's no such thing as "manipulating" that very basic fact. The mask is simply an interface at the airway and will not affect that pressure. The only difference there is are some full face masks that push the chin back when tightened requiring a slightly higher pressure.
you clearly do not come from a scientific background....the pressure can easily be manipulated by a variety of components between the CPAP machine and a humans lungs....
Complete hogwash. The mask is just an interface between the CPAP machine and the airway, and there is no mask/interface that will change the pressure that is required to keep the airway open. Think of the airway as a balloon, pressure holds it open, and that pressure will be the same regardless of what you use at its nozzle to get the air in.
lol i dont have OSA, just insanely bad year round allergies that severely limit my ability to breath freely so i am usually breathing through my mouth...i go for weekly shots, hopefully biweekly soon....its a pain in the ass getting stuck in each shoulder once a week and the nurses are so hit or miss, some i hardly feel and others jab you right in the muscle...
DeltaWave allowed me not to be a mouth breather! ????
i know your pain, hence my name haha! goodluck moving forward
I remember before I got the Deltawave and had covid the pressure mad me feel like I was being choked… my wife said I was awful to sleep in bed with
Allergies are still kicking my butt, but yes much better broke it multiple times back in college football and so for the last 10+ years I haven’t known what breathing normal has been like
TY Mouthbreather!
I had that surgery as well. Plus tonsilectomy and uvula removed as log shots of helping with the OSA. No joy. When the pressure is high I rip the mask off my face while I'm sleeping and wake up gasping for air like I was suffocating. The mask usually stays on for 45 minutes to 1.25 hours. I am wearing this mask all night on most nights. GLTU
bet you feel much better now though....my allergies are so bad its like having a deviated septum myself
I just recently had severe deviation correction surgery to help with my nose so for a few weeks i had to use full face one and pressure was around 10 using auto sense.
Yeh I got two with mine one smaller pillow and one larger pillow so technically two of them.
My resmed has auto pressure sense and I am at 5.0-6.5 range and hardly ever use any extra moisture even in winter
ASCENDING!!!!!!!..........
TRIANGLE!!!!!!!............
UNITE!!!!!!!!
happy to hear your positive review of the product, best of luck to you, your health and your financial health!!
Nice picture! I have two Deltawave masks the first one had a different angle on the elbow piece that connects the tube to the mask. Tom sent me the better angled one once he got the part produced. Did you lower you pressure? Mine went from 11-12 to 5.0-5.5. That helps me wear the the mask much longer than I have ever worn any other mask. This make me more compliant and my Sleep Dr was very happy about that. Good luck to you with your OSA and with RMSL!
I don’t pay for IHub so I don’t believe I can. Feel free to use my photo though if you can
thank you, can you post the pic here? i dont have ST
I posted a brand new photo taken this morning hooked up to my resmed airsense 11.
https://stocktwits.com/Tz3sports/message/463509189
I would be happy to post a brand new picture for you tomorrow morning hooked up to the actual machine.
Sample pics of the DeltaWave by pumpers claiming to have sleep apnea are always suspect. Funny that they never show a picture of the mask actually hooked up to a cpap machine.
Great. Could be Monday till the following week that we hear
correct, hoping they worked their kinks out
Not sure where you got that info from but that is how long uplisting to otcqb takes once application is accepted and fee paid
They said approximately 30 days FDA decision would be made. That puts it at June 6th. FDA gives themselves a 10 day window on decisions so it could happen as late as June 16th… either way it’s out of RMSLs hands and they like everybody else are simply waiting on FDA
30 days from may 6th
Wasn’t it two weeks ago they said 2 -4 weeks?
woooooooooooooooo!!!! waiting for some PR
Will explode with approval…
would love to see that, will make nice gains from such move
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REMSleep Holdings, Inc. is engaged in the business of developing and distributing sleep apnea products. The Company focuses on offering optimum compliance and comfort for continuous positive airway pressure (CPAP) patients. Its DeltaWave CPAP interface (the DeltaWave) is a device to treat patients with sleep apnea. Its DeltaWave product is a nasal-pillows type interface that is designed with airflow characteristics to enable patients with sleep apnea to breathe normally. Its product is manufactured by mold makers. Its target market includes home care dealers, private sleep labs, product end users, sleep physicians, medical groups, sleep product distributors, hospitals, medical associations, such as the American academy of sleep medicine and the American sleep association. REMSleep LLC is its wholly owned subsidiary.
INDUSTRY
Medical Equipment & Supplies
CONTACT INFO
2202 N. WEST SHORE BLVD SUITE 200
TAMPA, FL
33607
United States
+1.912.5902001
https://www.remsleep.com/EXECUTIVE LEADERSHIP
Russell Finlay Bird
Chairman of the Board
Thomas J. Wood
Chief Executive Officer, Director
Jonathan B Lane
Chief Technology Officer, Vice President
https://www.fundable.com/remsleep
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