# STEGNCE LYF TEK — CONTENT AUDIT: "TO BE CONFIRMED" REGISTER

This audit register compiles all technical values, regulatory milestones, clinical claims, and operational parameters that are currently designated as **"TO BE CONFIRMED"** or **"VERIFICATION PENDING"** on the website.

In adherence to medical device communication ethics, none of these values have been fabricated or assumed. They are displayed with transparent verification badges across the interface until certified by STEGNCE LYF TEK leadership and engineering authorities.

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## 1. Biomechanical & Engineering Specifications

| Specification Item | Website Display Status | Notes / Source Conflict |
| :--- | :--- | :--- |
| **Maximum Load** | `"Maximum load — Final verification pending"` | **Conflict Identified**: Requirements document references an **80 kg tested load**, whereas the portfolio presentation references **90 kg patient body weight**. Both are withheld from definitive claim until engineering sign-off. |
| **Overall Weight** | `"To be confirmed"` | Pending final calibrated scale measurement of the production unit. |
| **Overall Dimensions** | `"To be confirmed"` | Height, width, and depth in retracted/extended positions pending final production blueprint release. |
| **Operating Pressure** | `"To be confirmed"` | Sealed internal pneumatic operating pressure awaiting lab pressure sensor certification. |
| **Maximum Allowable Pressure** | `"To be confirmed"` | Burst/yield safety pressure limits pending mechanical stress testing. |
| **Stroke Length** | `"To be confirmed"` | Piston travel distance in full flexion to be confirmed with CAD model. |
| **Cylinder Bore & Rod Diameter** | `"To be confirmed"` | Precision internal machining dimensions pending engineering confirmation. |
| **Retracted / Extended Length** | `"To be confirmed"` | Biomechanical alignment heights pending finalized adapter selection. |
| **Extension & Retraction Speed** | `"To be confirmed"` | Variable flow rate curves pending clinical gait analysis lab report. |
| **Operating Temperature Range** | `"To be confirmed"` | Environmental stress test validation pending. |
| **Chassis / Frame Material** | `"High-Strength Aluminium Alloy / Steel (Final alloy grade to be confirmed)"` | Preliminary material family stated; exact aerospace/medical grade code pending confirmation. |
| **Expected Life / Cycles** | `"To be confirmed"` | Bench cyclic endurance test (e.g., ISO 10328 million-cycle endurance) in progress. |
| **Environmental Rating / Dust Resistance** | `"To be confirmed"` | Ingress protection testing pending. |
| **Acoustic Noise Level** | `"To be confirmed"` | Decibel measurement during swing phase dampening pending verification. |

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## 2. Regulatory, Quality & Legal Milestones

| Milestone / Standard | Current Website Representation | Verification Requirement |
| :--- | :--- | :--- |
| **ISO 13485:2016** | `"Certification in progress"` | Final audit date and certificate number required prior to claiming "ISO Certified". |
| **CDSCO (India)** | `"Regulatory submission in progress"` | Submission tracking number / formal approval letter required prior to claiming "CDSCO Approved". |
| **UDYAM Registration** | `UDYAM-AP-04-0130113` | Verified corporate MSME registration; properly segregated from medical device product certifications. |
| **DPIIT Recognition** | `DPIIT252862` | Verified startup India recognition; properly segregated from medical device product certifications. |
| **Patent No. 490014** | Cited for GROWSTEP Paediatric Limb | Patent registration acknowledged for telescopic pylon innovation; product clearly marked as `"IN DEVELOPMENT"`. |

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## 3. Clinical Claims & Patient Evaluations

| Claim / Item | Current Website Representation | Verification Requirement |
| :--- | :--- | :--- |
| **100+ Patient Evaluations** | **Withheld from publication**; timeline states `"Patient Evaluations — In Progress"` | Formal Institutional Review Board (IRB) or clinical trial registry reference required prior to publishing quantified patient numbers. |
| **Comparative Market Pricing** | Framed as `"Client-Provided Preliminary Claims — Subject to Final Market Verification"` | Domestic cost range (₹15k–₹50k) vs imported alternatives (₹2L–₹20L) clearly flagged as client-reported estimates. |
| **Distribution Channels** | Listed as `"Potential Distribution Channels"` | Direct empanelment or partnership with PMJAY, ADIP, ALIMCO, or State Hospitals requires executed MOU/tender confirmation. |

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## 4. Omitted Non-Relevant Content

- **"Nutrition and Its Role in Health"**: Completely excluded from the website architecture and copy, as it is unrelated to Sthirā Knee prosthetic engineering.