510(k) K111557
K111557 is an FDA 510(k) premarket notification submitted by Seven Seas Distribtion and Manufacturing, LLC for the device "X-FORCE". The FDA issued a decision of Substantially Equivalent on November 10, 2011. The device falls under product code NYN (Stimulator, Electrical, Transcutaneous, For Arthritis), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2011
- Date Received
- June 3, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Transcutaneous, For Arthritis
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).