FDA 510(k) Application Details - K241256

Device Classification Name Massager, Powered Inflatable Tube

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510(K) Number K241256
Device Name Massager, Powered Inflatable Tube
Applicant Therabody, Inc.
1640 S Sepulveda Blvd
Suite 300
Los Angeles, CA 90025 US
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Contact CJ Frederick, III
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Regulation Number 890.5650

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Classification Product Code IRP
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Date Received 05/06/2024
Decision Date 08/30/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241256


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