secwatch.observer — SEC 8-K summary
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Issuer:     RemSleep Holdings Inc. (RMSL)
CIK:        0001412126
Form:       8-K
Filed at:   2022-06-09T23:59:59+00:00
Accession:  0001213900-22-031914
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

RemSleep DeltaWave reclassified as implantable by FDA; must resubmit 510K after new testing
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- FDA reclassified DeltaWave as implantable device; company withdrawing current 510K application.
- Additional testing required; RemSleep engaging consultants to satisfy new classification.
- FDA confirmed all previously submitted test results will apply to the new 510K submission.
- Company plans to submit next 510K for next-generation Nasal Pillows interface soon.
- OTCQB application is in final stages of completion by securities attorney.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1412126/000121390022031914/0001213900-22-031914-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1412126/000121390022031914/ea161380-8k_remsleep.htm
  HTML page:      https://secwatch.observer/filing/0001213900-22-031914

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer