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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name massager, therapeutic, electric
510(k) Number K210166
Device Name Omnispec ED1000
Applicant
Medispec Ltd.
203 Perry Parkway, Suite 6
Gaithersburg,  MD  20877
Applicant Contact Avner Spector
Correspondent
Medispec Ltd.
203 Perry Parkway, Suite 6
Gaithersburg,  MD  20877
Correspondent Contact Avner Spector
Regulation Number890.5660
Classification Product Code
ISA  
Date Received01/21/2021
Decision Date 01/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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