510(k) K190251

RecoveryRx by Bioelectronics Corporation — Product Code ILX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2019
Date Received
February 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type