---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-22-031914"
form_type: "8-K"
ticker: "RMSL"
cik: "0001412126"
company_name: "RemSleep Holdings Inc."
filed_at: "2022-06-09T23:59:59+00:00"
generated_at: "2026-06-25T03:06:36.604962+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# RemSleep DeltaWave reclassified as implantable by FDA; must resubmit 510K after new testing

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-22-031914
- form_type: 8-K
- ticker: RMSL
- cik: 0001412126
- company_name: RemSleep Holdings Inc.
- filed_at: 2022-06-09T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1412126/000121390022031914/0001213900-22-031914-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1412126/000121390022031914/ea161380-8k_remsleep.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-22-031914
- JSON: https://secwatch.observer/filing/0001213900-22-031914.json
- Plain text: https://secwatch.observer/filing/0001213900-22-031914.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.