# K052625: Bionicare Stimulator System, Model Bio-1000

- Pathway: 510(k) (Traditional)
- Applicant: Bionicare Medical Technologies, Inc.
- Decided: Dec 5, 2005 after 73 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: 2 generations back to K971437 (1997). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030332: Modification to Bionicare Stimulator System, Model Bio-1000, Bionicare Medical Technologies, Inc. (2003) Summary page 1.
- K983228: Bionicare Stimilator System, Model Bio-1000, Murray Electronics (1999) Summary page 1.

## Most influential descendants
- K073386: Joint Stim, Model 1000 (2008), 1 descendant of its own
- K142236: BioniCare Hand System (2015), 0 descendants of its own
- K111557: X-Force (2011), 0 descendants of its own

## Indications for use
The BioniCare Stimulator, Model BIO-1000™, 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.

Source page: https://510kreport.com/device/K052625
Methodology: https://510kreport.com/methodology