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510(k) K821836

PREGNANCY (W) EDGE by Body Therapeutics, Inc. — Product Code QSB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 30, 1982
Date Received: June 22, 1982
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthosis, Truncal, Pregnancy
Device Class: Class I
Regulation Number: 890.3490
Review Panel: OB
Submission Type

Provide abdominal and back support during pregnancy