The following data is part of a premarket notification filed by Vision Quest Industries, Inc. with the FDA for Bionicare Hand System.
| Device ID | K142236 |
| 510k Number | K142236 |
| Device Name: | BioniCare Hand System |
| Classification | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Applicant | VISION QUEST INDUSTRIES, INC. 1390 DECISION STREET, SUITE A Vista, CA 92081 |
| Contact | Mohamed Ouerghi |
| Correspondent | Mohamed Ouerghi VISION QUEST INDUSTRIES, INC. 1390 DECISION STREET, SUITE A Vista, CA 92081 |
| Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-13 |
| Decision Date | 2015-03-23 |
| Summary: | summary |