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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BOUNDER
Classification Name: WHEELCHAIR, POWERED
Product Code: ITI
Device Class: 2
Regulation Number: 890.3860
Medical Specialty: Physical Medicine
Registered Establishment Name: 21ST CENTURY SCIENTIFIC, INC.
Registered Establishment Number: 2027797
Premarket Submission Number: K193599
Owner/Operator: 21ST CENTURY SCIENTIFIC, INC.
Owner/Operator Number: 9000697
Establishment Operations: Manufacturer
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