483
Excite Medical of Tampa Bay LLCExcite Medical of Tampa Bay LLC – FDA 483, Aug 25, 2022
Record Details
An FDA inspection of Excite Medical of Tampa Bay LLC in Tampa, FL, a refurbisher and servicing establishment, revealed two significant observations. The firm was cited for failing to include required information in service reports for its DRX9000 Non-surgical Spinal Decompression Systems. Additionally, the firm's written Medical Device Reporting (MDR) procedures were found to be incomplete, lacking definitions for key terms like "MDR reportable event" and "Serious injury".
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ID · b2dec88d-1633-43e4-ab66-54cda940a3bf
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