{"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","discovered_at":"2026-05-14T18:04:00.583831+00:00","generated_at":"2026-06-25T03:06:36.604962+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"RemSleep DeltaWave reclassified as implantable by FDA; must resubmit 510K after new testing","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-22-031914","json":"https://secwatch.observer/filing/0001213900-22-031914.json","markdown":"https://secwatch.observer/filing/0001213900-22-031914.md","text":"https://secwatch.observer/filing/0001213900-22-031914.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T03:06:36.604962+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}