510(k) K851511
K851511 is an FDA 510(k) premarket notification submitted by Sunnex, Inc. for the device "ACCURATECARE I & ACCURATECARE II". The FDA issued a decision of Substantially Equivalent on July 1, 1985. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Sunnex, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1985
- Date Received
- April 15, 1985
- 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