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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 Pkwy.,
Suite #6
Gaithersburg,  MD  20877
Applicant Contact Avner Spector
Correspondent
Medispec, Ltd.
203 Perry Pkwy.,
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
Predetermined Change
Control Plan Authorized		 No
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