Zeobi

FDA 510(k) K121338 · Ivivi Health Science, LLC

Substantially Equivalent

510(k) numberK121338

Submission

Device name
Zeobi
Applicant
Ivivi Health Science, LLC
San Francisco, CA, US
Received
May 3, 2012
Decision date
July 27, 2012
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5290
Specialty
Physical Medicine

Other 510(k)s with product code ILX

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K190251RecoveryRxILX · Traditional Bioelectronics Corporation06/28/2019SE
K131979Provant Therapy SystemILX · Traditional Regenesis Biomedical, Inc.12/13/2013SE
K121702Orthocor Active Device Orthocor General Use Active DeviceILX · Traditional Orthocor Medical05/06/2013SE
K091791Provant System, Model 4201ILX · Traditional Regenesis Biomedical, Inc.04/07/2010SE
K092044Orthocor Knee System, Median, Large, X-LargeILX · Traditional Orthocor Medical12/18/2009SE
K091996Orthocor Knee System BasicILX · Traditional Orthocor Medical12/15/2009SE
K070541Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIILX · Traditional Ivivi Technologies, Inc.12/11/2008SE
K070931Model PMT850ILX · Traditional Promedtek, Inc.05/24/2007SE

Questions and answers

When was Zeobi cleared by the FDA?

Zeobi (K121338) received a 510(k) decision of Substantially Equivalent on July 27, 2012, 85 days after the submission was received.

What is the product code of K121338?

The FDA product code is ILX – Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.