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510(k) K121338

ZEOBI by Ivivi Health Science, LLC — Product Code ILX

K121338 is an FDA 510(k) premarket notification submitted by Ivivi Health Science, LLC for the device "ZEOBI". The FDA issued a decision of Substantially Equivalent on July 27, 2012. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2012
Date Received
May 3, 2012
Clearance Type
Special
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

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  • K131979 — PROVANT THERAPY SYSTEM (December 13, 2013)
  • K121702 — ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE (May 6, 2013)
  • K091791 — PROVANT SYSTEM, MODEL 4201 (April 7, 2010)
  • K092044 — ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE (December 18, 2009)
  • K091996 — ORTHOCOR KNEE SYSTEM BASIC (December 15, 2009)
  • K070541 — IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II (December 11, 2008)
  • K070931 — MODEL PMT850 (May 24, 2007)

FDA data resources