510(k) K011543
K011543 is an FDA 510(k) premarket notification submitted by Tenscare, Ltd. for the device "TENS CARE, MODEL XL-Y3". The FDA issued a decision of Substantially Equivalent on August 31, 2001. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Tenscare, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2001
- Date Received
- May 18, 2001
- 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