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FDA 510(k), K052711, EMJOI TENS DEVICE
FDA 510(k), K052711, EMJOI TENS DEVICE
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510(K) Number: K052711
Device Name: EMJOI TENS DEVICE
Manufacturer: MIKE JUDGE
Device Classification Name: Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation Number: GZJ
Classification Product Code: KXA
Date Received: 09/29/2005
Decision Date: 06/23/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: EMJOI TENS DEVICE
Manufacturer: MIKE JUDGE
Device Classification Name: Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation Number: GZJ
Classification Product Code: KXA
Date Received: 09/29/2005
Decision Date: 06/23/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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