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510(k) K191547

ReliefBand by Reliefband Technologies, LLC — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2019
Date Received
June 12, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Reliefband Technologies, LLC

  • K182960 — ReliefBand (June 21, 2019)
  • K173233 — ReliefBand 1.5 (November 30, 2017)

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