510(k) K142666
K142666 is an FDA 510(k) premarket notification submitted by Delta International Services & Logistics S.R.L for the device "Scrambler Therapy MC-5 A Device". The FDA issued a decision of Substantially Equivalent on May 22, 2015. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Delta International Services & Logistics S.R.L has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2015
- Date Received
- September 18, 2014
- 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