510(k) K073386
K073386 is an FDA 510(k) premarket notification submitted by Pain Management Technologies for the device "JOINT STIM, MODEL 1000". The FDA issued a decision of Substantially Equivalent on July 30, 2008. The device falls under product code NYN (Stimulator, Electrical, Transcutaneous, For Arthritis), a Class II device regulated under 21 CFR 882.5890. Pain Management Technologies has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 2008
- Date Received
- December 3, 2007
- 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).