510(k) K983228
K983228 is an FDA 510(k) premarket notification submitted by Murray Electronics for the device "BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000". The FDA issued a decision of Substantially Equivalent on March 15, 1999. The device falls under product code NYN (Stimulator, Electrical, Transcutaneous, For Arthritis), a Class II device regulated under 21 CFR 882.5890. Murray Electronics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 1999
- Date Received
- September 15, 1998
- 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).