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Haha...that's not a quote from the PR...let me help you:
NASAL PILLOWS interface.
https://www.otcmarkets.com/stock/RMSL/news/story?e&id=2233548
Pretty clear from PR
“2nd CPAP mask.”
Strange logic. Uplisting doesn't prove anything. All folks have to do is email Tom and ask him if the NASAL PILLOWS he referenced in the shareholder letter is a UNIQUE mask or if it's an attachment to the EXISTING Deltawave.
Are people still going to try and claim there isn’t a second mask?
Uplisting to the OTCQB® will assist our company in providing greater shareholder value by allowing us to achieve greater market visibility, expand our potential prospective investor pool, greater share price stability, along with increased trading liquidity within the investment community. We look forward to broadening our company exposure to a larger and more diverse demographic of both domestic and international investors,” stated Tom Wood, RemSleep CEO. Wood continued “Uplisting to OTCQB® is the one of several exciting developments we have on the horizon. We are confident in obtaining FDA approval for our patented DeltaWave CPAP nasal interface, and our subsequent upcoming 510k FDA application for our 2nd CPAP mask. We also have our recent CPAP machine distribution deal that is progressing well, and are currently transitioning from a pre-revenue company to a positive cash flow and profitable company. I could not be more excited for what we have in store for our investors and the entire CPAP industry as a whole. We believe that are positioning RemSleep to be a disruptive force within the CPAP industry for years to come.”
Funny that you won't email Tom.
A strap and tube remain the same… the treatment part of all masks is the interface. Twist words however you want it’s a new mask.
Tom isn't going to say it's a mask because it's not and that's why there will be no email.
Nasal pillows is a component part or "interface" of the mask.
This is CPAP 101.
I don’t need an email from him because I use the Deltawave and can actually read the PR… 510k isn’t submitted on only a section….
510k is submitted on the full mask just as with Deltawave…
“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”
Email Tom and get him to say it's a mask....I'll wait.
This is the 510k number they've been using since 7/15/21:
https://www.globenewswire.com/en/news-release/2021/07/15/2263714/0/en/REMSleep-510K-Submission.html
The mask is the whole thing, pillows, the base that the pillows snap into, and the headgear. The pillows are a twice per month replacement item per most insurance carriers. The mask is 6 months, headgear 3 months (might be vice-versa on that). Most CPAP users on the discussion forums get much more life out of all 3 of those items through proper cleaning and care. When I used the P10, I'd go 3-4 months on pillows, up to a year on headgear and mask. The headgear is the challenge, tends to stretch.
For full face masks, you can get a "cushion" once per month.
RemSleep's claims is for the whole mask, which would be appropriate. Not a chance in hades that Resmed would let stand anyone trying to snap an alternate pillows into their P10.
I looked on the FDA website for RemSleep's application, couldn't find it. Does anyone have the number?
RMSL updated that they would be offering new pillow sizes on their old Twitter account that they deleted after they claimed it was "fake" two years ago.
Do you not know that for a pillow mask the photo you just shared is the actual mask… only thing that is missing is the strap attachment… ???????
made all my money back from my loss here on the oil momentum plays in a day.....lolzzzzzzzzzz gotta love it, could buy twice as much now if i wanted to, but i dont
Tom should file the FDA letter in an 8k.
It's a time/date stamped letter that companies are required to provide to shareholders.
He sat on the info in typical Tom fashion for NINE DAYS. That letter would shed a lot of light as to why.
Lol. I tried my hand on OTC and dumped almost all of the tickers I bought in to within a year. Should have just stuck with the big boards.
I'm even smarter than you. I never bought this garbage. Its a bigger scam than ILUS, HMBL and SHMP combined.
God I am glad I got out of this last year. Got a notification and was wondering why pps was down 50%. 124M share in V? Looks like that discount on common stock in December is really paying off. lol. Over $2M in trading so someone is getting paid. Glad I finally got one right in time and dumped. Sorry to those who trusted Tom and held.
back to the drawing board fella's! i'll keep an eye but not getting married to the stock....GL!!
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.
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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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