# K030332: Modification to Bionicare Stimulator System, Model Bio-1000

- Pathway: 510(k) (Special)
- Applicant: Bionicare Medical Technologies, Inc.
- Decided: Jun 6, 2003 after 126 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
No predicates in its family tree.
7 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BioniCare Stimulator, Model BIO-1000: named in the summary without a submission number

## Most influential descendants
- K052625: Bionicare Stimulator System, Model Bio-1000 (2005), 3 descendants of its own
- K060669: Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300 (2006), 2 descendants of its own
- 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 symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician’s global evaluation (clinical studies.)

Source page: https://510kreport.com/device/K030332
Methodology: https://510kreport.com/methodology