510(k) K142236
K142236 is an FDA 510(k) premarket notification submitted by Vision Quest Industries, Inc. for the device "BioniCare Hand System". The FDA issued a decision of Substantially Equivalent on March 23, 2015. The device falls under product code NYN (Stimulator, Electrical, Transcutaneous, For Arthritis), a Class II device regulated under 21 CFR 882.5890. Vision Quest Industries, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2015
- Date Received
- August 13, 2014
- 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).