SHOCKWAVE PRO USA LLC IS A REGISTERED FDA MEDICAL DEVICE MANUFACTURER FACILITY
This device is marketed as an FDA 510K Exempt Class I Medical Device Under regulation
§890.5660 Electromagnetic Therapeutic Device, FDA Classification ISA
PART 890 -- PHYSICAL MEDICINE DEVICES
Premarket notification application and FDA clearance is not required before marketing an FDA 510K Exempt Class I medical device in the U.S. so long as the manufacture is a registered FDA facility.
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)
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