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510(k) K060246

INFREX by Johari Digital Healthcare , Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2006
Date Received
January 31, 2006
Clearance Type
Traditional
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 Johari Digital Healthcare , Ltd.

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  • K112351 — ULTRA BEAUTY (March 30, 2012)
  • K102190 — WINSTIM (March 17, 2011)
  • K090052 — CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C (May 29, 2009)
  • K062439 — POWERTONE, MODEL PT-11 (January 8, 2007)
  • K024036 — PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 (December 20, 2002)

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