510(k) K971437
K971437 is an FDA 510(k) premarket notification submitted by Murray Electronics for the device "BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000". The FDA issued a decision of Substantially Equivalent on July 22, 1997. 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
- July 22, 1997
- Date Received
- April 18, 1997
- 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).