SHOCKWAVE PRO USA LLC IS A SUBSIDIARY OF ASCLEPIUS MEDICAL HOLDINGS LLC 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

THESE DOCUMENTS CONTAIN PROPRIETARY AND SENSITIVE INFORMATION

DOCUMENTS ARE ON FILE AND MADE ONLY AVAILABLE TO THE FDA AND AUTHORIZED REGULATORY AGENCIES

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

ADDITIONAL CERTIFICATIONS

THESE DOCUMENTS CONTAIN PROPRIETARY AND SENSITIVE INFORMATION

DOCUMENTS ARE ON FILE AND MADE ONLY AVAILABLE TO THE FDA AND AUTHORIZED REGULATORY AGENCIES

Certificate of Conformity

Electromagnetic Compliance Test Report

EU Electromagnetic Compliance Directive

EU Low Voltage Directive

Low Voltage Testing Report

Certified Medical Device (MD)

ISO CERTIFICATIONS

THESE DOCUMENTS CONTAIN PROPRIETARY AND SENSITIVE INFORMATION

DOCUMENTS ARE ON FILE AND MADE ONLY AVAILABLE TO THE FDA AND AUTHORIZED REGULATORY AGENCIES

Specific To Medical Device Manufacturers
13485:2016, 14971:2019, 24971:2020