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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manipulator, Plunger-Like Joint
510(k) Number K172536
Device Name Atlas Percussion Adjusting Instrument
Applicant
Spinalight, Inc.
6721 23rd St. N.
St. Petersburg,  FL  33702
Applicant Contact Stanford Pierce
Correspondent
Spinalight, Inc.
6721 23rd St. N.
St. Petersburg,  FL  33702
Correspondent Contact Stanford Pierce
Classification Product Code
LXM  
Date Received08/22/2017
Decision Date 06/20/2018
Decision Substantially Equivalent (SESE)
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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