# K142236: BioniCare Hand System

- Pathway: 510(k) (Traditional)
- Applicant: Vision Quest Industries, Inc.
- Decided: Mar 23, 2015 after 222 days
- Product code: NYN (Stimulator, Electrical, Transcutaneous, For Arthritis)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971437 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052625: Bionicare Stimulator System, Model Bio-1000, Bionicare Medical Technologies, Inc. (2005) Summary page 4.
- K030332: Modification to Bionicare Stimulator System, Model Bio-1000, Bionicare Medical Technologies, Inc. (2003) Summary page 4.

## Indications for use
The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand. The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in osteoarthritis of the hand to reduce the level of pain and stiffness and to improve the function of the hand.

Source page: https://510kreport.com/device/K142236
Methodology: https://510kreport.com/methodology