TERMS & CONDITIONS

1. Acceptance of Terms

By accessing this website and purchasing or using our products, you agree to be bound by these Terms & Conditions. If you do not agree, you may not purchase or use the device.

2. Device Classification & Regulatory Status

The JFord Speculum Sleeve (the device) is a Class II medical device regulated by the U.S. Food and Drug Administration.

The device is cleared for use only for its intended use(s) as described in its labeling and Instructions for Use (“IFU”). Use outside of these indications is strictly prohibited.

3. Intended Users

You represent and warrant that:

• You are:
• A licensed healthcare professional; OR
• Purchasing on behalf of a licensed healthcare provider or healthcare facility

4. No Medical Advice

All content on this website is provided for informational purposes only and does not constitute medical advice, diagnosis, or treatment.

5. Proper Use & Handling

You agree to:

• Read and follow the Instructions for Use (IFU) prior to use
• Use the device only for its intended OB-GYN clinical purpose
• Use the device only in appropriate clinical settings by trained personnel
• Do not alter, modify, or misuse the device

Failure to comply may result in patient harm and void any applicable warranties.

6. Orders & Eligibility

We reserve the right to:

• Verify purchaser eligibility (including healthcare professional status)
• Refuse or cancel any order at our discretion
• Limit order quantities

Orders are not final until accepted and processed.

7. Pricing, Payment & Taxes

• Prices are subject to change without notice
• You agree to provide accurate billing and payment information
• You are responsible for all applicable taxes and fees

For healthcare facilities, invoicing or net payment terms may be offered upon approval.

8. Shipping, Title & Risk of Loss

• Title and risk of loss transfer upon delivery
• You are responsible for proper storage, handling, and use after receipt

9. Returns & Product Condition

Because this is a non-sterile medical device:

• Returns may be accepted within 30 days if:
• Product box is unopened and in original condition
• Opened boxes may not be returned except in cases of defect or warranty claim
• All returns require prior authorization

We reserve the right to inspect returned products.

10. Product Complaints & Adverse Event Reporting

You agree to promptly report:

• Product defects or malfunctions
• Any adverse events, injuries, or safety concerns

This supports compliance with FDA post-market surveillance requirements.

11. Traceability & Device Identification

We maintain records consistent with the

• Unique Device Identification (UDI) system

You agree to:

• Retain packaging or device identification where possible
• Cooperate in the event of a recall or safety notification

12. Limited Warranty

The device is warranted only as described in its official labeling.

EXCEPT AS EXPRESSLY PROVIDED:

• THE DEVICE IS PROVIDED “AS IS”
• NO IMPLIED WARRANTIES (INCLUDING MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) APPLY

13. Limitation of Liability

To the fullest extent permitted by law:

• We are not liable for indirect, incidental, or consequential damages
• Our total liability shall not exceed the purchase price of the device

This includes damages arising from:

• Improper use
• Failure to follow IFU
• Use outside intended indications
• Improper storage or handling

14. Indemnification

You agree to indemnify and hold harmless Ford Medtech from any claims arising from:

• Misuse of the device
• Use outside cleared indications
• Failure to follow IFU or applicable regulations

15. Healthcare Facility Responsibilities (B2B)

If purchasing on behalf of a clinic, hospital, or practice, you agree that:

• The device will be used only by appropriately trained personnel
• Your organization is responsible for credentialing users
• Proper clinical protocols, cleaning, and handling procedures are followed

16. Compliance with Laws

You agree to comply with all applicable laws and regulations, including those governing:

• Medical device use
• Professional licensing
• Healthcare delivery

17. Privacy & Data

We handle personal information in accordance with applicable laws.

Do not submit any protected health information (PHI).

18. Intellectual Property

All website content, trademarks, and product materials are owned by Ford Medtech and may not be used without permission.

19. Governing Law

These Terms shall be governed by the laws of the State of New York, without regard to conflict of law principles.

20. Changes to Terms

We reserve the right to update these Terms at any time. Continued use of the website constitutes acceptance of any updates.