LEGAL DISCLAIMER
Legal Disclaimer
This legal disclaimer ("Disclaimer") applies to the purchase and use of any medical device manufactured or distributed by SHOCKWAVE PRO USA LLC ("Manufacturer").
1. Authorized Purchasers
Purchases of any medical device from SHOCKWAVE PRO USA LLC ("Device") are strictly limited to properly licensed medical professionals. By purchasing a Device, the purchaser ("Purchaser") affirms that they are a licensed medical professional with the authority to operate and use such medical equipment in accordance with applicable laws and regulations.
2. Insurance Requirements
The Purchaser is required to maintain proper and adequate medical malpractice insurance and commercial liability insurance at all times during the possession and use of the Device. Proof of such insurance may be requested by the Manufacturer at any time.
3. Prohibited Uses and Warranty Voiding
The use of the Device for any unspecified or off-label purposes is strictly prohibited. Any such use will immediately void the warranty provided by the Manufacturer. The Manufacturer shall not be held liable for any damages, injuries, or other consequences arising from the use of the Device outside of the specified and approved operating parameters as outlined in the product documentation. Any use outside that described in the operating manual will be considered a warranty voiding event.
4. Release of Liability
By purchasing the Device, the Purchaser releases SHOCKWAVE PRO USA LLC from any and all liability related to the use of the Device outside of any and all listed and specified operating parameters. The Manufacturer is not responsible for any misuse, unauthorized use, or use that is inconsistent with the instructions and guidelines provided with the Device. By purchasing this device the purchaser releases this company and the manufacturer of any and all liability related to injury of a patient during the use of the machine outside of any and all operational instructions and guidelines. Including power to frequency ratio, improper care or maintenance of the machine.
5. Instructional Materials
All instructional materials, manuals, and guidelines provided by SHOCKWAVE PRO USA LLC are assumed to have been read and understood by the Purchaser. The Purchaser agrees to strictly adhere to all instructions contained in any material provided by the Manufacturer prior to the delivery and operation of the Device. Failure to follow these instructions may result in injury, damage, or other adverse consequences, for which the Manufacturer disclaims all responsibility.
6. Acknowledgment
By purchasing and using the Device, the Purchaser acknowledges that they have read and understood this Disclaimer, and agree to abide by all terms and conditions contained herein.
7. CLAIMS MADE
This manufacture does not claim that this machine can cure any disease or musculoskeletal condition. This manufacture has made no claim that this device has been evaluated by the FDA or approved in any way by the FDA, or our facility. Any claims made by the manufacturer are clinical observations by licensed medical professionals utilizing the device. Their claims have not been approved or evaluated by the FDA. This device carries a current FDA 510K Premarket Registration Predicate.
SHOCKWAVE PRO USA LLC
Date: 07-01-2024
This Disclaimer may be updated from time to time. Please review it regularly to stay informed of any changes.
FDA COMPLIANCE DOCUMENTS
THIS DOCUMENTS CONTAIN PROPRIETARY AND SENSITIVE INFORMATION
DOCUMENTS ARE ON FILE AND MADE ONLY AVAILABLE TO THE FDA AND AUTHORIZED PARTIES
Quality Manual
Design Control Process
Document Control Process
Training and Competency Process
Purchasing and Receiving Process
Labelling and Packaging Control Process
Identification and Traceability Process
Nonconforming Product Process
Change Control Process
Software Validation Process
Customer Complaints and Advisory Notice Process
Corrective and Preventive Action Process
Management Review and Data Analysis Process
Calibration and Preventive Maintenance Process
Quality Audit Process
Risk Management Process
Record Management Process
FDA Audit Management Process
Medical Device Reporting and Recall Process
Infrastructure and Work Environment
Supplier Management Process
Post Market Surveillance Process
Unique Device Identification Process
Process Validation Process
Additional Considerations
Establishment Registration and Listing
Quality Agreements
Quality Policy
SHOCKWAVE PRO USA LLC is a registered FDA Medical Device Manufacturer & Distributor
Registration is current and active through 12-31-2024
ADDITIONAL CERTIFICATIONS
THESE DOCUMENTS CONTAIN PROPIETY AND SENSITIVE INFORMATION
THESE DOCUMENTS ARE AVAILABLE ONLY TO REGULATORY AGENCIES AND BODIES AND AUTHORIZED PARTIES
Certificate of Conformity
Electromagnetic Compliance Test Report
EU Electromagnetic Compliance Directive
EU Low Voltage Directive
Low Voltage Testing Report
Certified Medical Device (MD)
Have questions? Easy, just send us a message
Text of Call 1-877-848-1110
or email us at [email protected]
