Cruxi
Recorded device evidence
The acquired K171397 file contains product-specific indications and users, design and operating principle, performance evidence actually described sections. Compare these dated manufacturer statements with your own indication and design before commissioning evidence work. They describe this submission; they do not prescribe your testing, validate performance independently or establish a suitable predicate.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Computed exact-code research
The 2021–2025 complete-year cohort contains 10 selected decisions under primary code GWL. 10 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
No quartiles are displayed: this complete-year cohort has fewer than 20 valid pairs.
The table shows the named decision and up to four latest exact-code research records through 2026-09-27. It can include partial-year records outside the complete-year cohort. The quartiles above use the full stated cohort, not this displayed selection.
| Research record | Recorded device | Receipt → decision | Calendar elapsed days | Recorded submission type |
|---|---|---|---|---|
| K171397 ↗ · this page | Sienna Ultimate Wireless Amplifier | 2017-05-11 → 2017-10-06 | 148 | Traditional |
| K243746 ↗ | Delphi Amplifier | 2024-12-05 → 2025-03-12 | 97 | Traditional |
| K242832 ↗ | NExT Station; NExT Station Advanced | 2024-09-19 → 2024-12-12 | 84 | Special |
| K242305 ↗ | BE Plus PRO, Neurotravel LIGHT | 2024-08-05 → 2024-09-04 | 30 | Special |
| K240646 ↗ | DreamClear | 2024-03-07 → 2024-09-04 | 181 | Traditional |
Use this comparison: select a record to investigate, read its actual indications and design, and document differences. A shared code or elapsed period cannot establish its relevance to your device.
Calendar elapsed days are not active FDA review time, a promised schedule or a success probability. The selection includes only the stated recorded decisions, not all applications. Latest records can postdate the named historical decision and are contextual research, not its predicates. Shared codes, summaries and observed records do not prove equivalence, current market availability, buyer applicability or predicate suitability.
Reuse the complete-endpoint exact-primary-code, documented SE-decision cohort and its stated cutoff/window. Retain its type-7 quartiles only when at least 20 valid date pairs are present. Independently subtract the named official record’s receipt date from its decision date; missing or negative pairs remain unknown. Show up to four latest exact-code research records, excluding the named ID. Parent analysis hash, source snapshots and calculation versions are retained.
Calculation: fda-named-decision-cohort-context-1; cutoff 2026-09-27; 0 parent records excluded; units record counts; calendar elapsed days.
Source snapshots: 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002.
Read beyond the decision row
The summary is manufacturer-submitted context hosted by FDA. Negative/no-study statements are preserved. Evidence themes are not binding legal requirements.
Short opening excerpts identify the source sections. Read the linked original for the full study context, negative statements, tables and limitations. Public quotations are limited to 120 words per acquired summary; the internal evidence packet retains exact section ranges for review.
K171397 · PDF page 3 ↗ Source 2
The Sienna Ultimate EEG amplifier is intended to be used as a front end amplifier to acquire, store and transmit electrophysiological signals in a wired or wireless mode for the EMS Neurodiagnostic system.
Compare with your product: Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
K171397 · PDF page 4 ↗ Source 3
The Sienna Ultimate is a small portable device which is capable of acquiring a variety of electrophysiological signals at variable sampling frequencies and can be used in a wide variety of EEG applications.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
K171397 · PDF page 9 ↗ Source 4
Safety Testing
Test Test description Purpose Results
Basic safety test Medical electrical equipment – Part This standard applies to There were no deviations
1: General requirements for basic Medical electrical from the standard and the
IEC 60601-1:2012 ed.The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: The source labels this section as performance data. Determine which described evidence is bench, software, biological or clinical from the actual narrative and original tables; the section label alone does not settle that distinction or prescribe your testing.
Select observed whole-line section headings or explicit colon-delimited inline labels on readable PDF pages, including the explicitly documented heading-spacing variants in this parser version. Preserve the original heading, character ranges and layout; do not repair excerpt text. Exclude letter boilerplate and uncertain pages. Stop at observed table headings; do not infer table columns or scalar results from layout text. Multi-column or suspicious split-numeric excerpts are excluded until reviewed alternate extraction is available. Original layout records remain retained; any alternate text has its own extractor-version locator and requires original-page review. For each dimension, prefer usable versioned alternate text where available, selecting its longest usable excerpt; otherwise select the longest usable original-layout excerpt. Ties preserve source order. Bounded to 64 PDF pages and 3,500 characters per section. This is a selection, not a complete dossier analysis.
Excluded extraction items: {}.
Read each mention in the linked original summary, including statements that testing was not performed. Recognition metadata does not determine your testing needs, chosen edition or transition eligibility.
| Reference in this historical summary | Designation in the acquired FDA export | Recognition / entry date | Recorded transition-expiration date | Sources |
|---|---|---|---|---|
| IEC 60601-1:2012 PERFORMANCE DATA | IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. | 19-49 · Complete 04/03/2023 | Not recorded in this export row | Summary [4] · Metadata [5] Read scope and recognition limits ↗ |
Prepare for your provider: the proposed protocol/report edition, its justification for your device and the complete current FDA recognition sheet. In particular, inspect exclusions for partial recognition. An edition difference does not automatically make the historical evidence unusable.
Match explicit ISO/IEC identifiers in selected preserved summary excerpts to the acquired, count-reconciled FDA metadata export. Preserve the historical edition mention, current snapshot designations, entry dates, recognition extent and any recorded transition-expiration date as separate facts. No title-similarity, edition-equivalence, test-mandate or transition-eligibility inference. At most twenty matched occurrences and thirty metadata rows per reference; wide matches are held for separate review.
1 of 1 matched reference occurrences shown.
Known context: US. Confirm the organisation’s role, relevant activities and markets against the cited criteria.
| Source fact | Recorded value | What to check |
|---|---|---|
| 510(k) identifier | K171397 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Generic device category | Sienna Ultimate Wireless Amplifier [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Recorded applicant | Ems Handels Gesellschaft M.B.H. [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| FDA product code | GWL [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Decision date | 2017-10-06 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Recorded decision code | SESE [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Submission type | Traditional [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Receipt date | 2017-05-11 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
Useful evidence: Our proposed indication, user/population and use environment beside this exact recorded indication.
Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
Useful evidence: Design description, materials/components, accessory list and a differences matrix.
The source labels this section as performance data. Determine which described evidence is bench, software, biological or clinical from the actual narrative and original tables; the section label alone does not settle that distinction or prescribe your testing.
Useful evidence: The cited narrative and full tables, underlying protocols/results and a reviewed comparison with the proposed product.
Compare each historical reference below with the dated FDA metadata. Ask the specialist to justify the applicable scope and selected edition, read the complete supplementary sheet for partial-recognition exclusions, and investigate any recorded transition conditions. A difference in editions does not automatically make the earlier study unusable.
Useful evidence: Proposed protocol/report edition, dated FDA recognition sheet with scope/exclusions, and a documented edition/transition rationale for the actual device.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Mon, 06 Nov 2017 13:22:41 GMT · retrieved 2026-10-07
Source key D02 · snapshot 06cd112e6da8c38b777520b8d64ca7c60efee0a7ac6bba95a7753c922e621cd2
Version not stated by the source · retrieved 2026-10-07
Source key D02 · snapshot 94ccf56dc846c7f6d78d6ad77dc6e87d1803ac3612af01d6894949e34c4a78d8
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.