# K971437: Bionicare Stimulator System. Model Bio-1000

- Pathway: 510(k) (Traditional)
- Applicant: Murray Electronics
- Decided: Jul 22, 1997 after 95 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.
19 later devices descend from it; 4 cite it directly.
0 of 20 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) Verite V/PPR 800: named in the summary without a submission number
- (no number) Medgeneral Mlmceptor: named in the summary without a submission number
- (no number) Medgeneral Mlmceptor: named in the summary without a submission number

## Most influential descendants
- K110350: Kneehab XP (2011), 9 descendants of its own
- K150413: QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator (2015), 7 descendants of its own
- K983228: Bionicare Stimilator System, Model Bio-1000 (1999), 7 descendants of its own
- K163067: CyMedica e-vive™ System; CY-1000 (2016), 4 descendants of its own
- K052625: Bionicare Stimulator System, Model Bio-1000 (2005), 3 descendants of its own

## Indications for use
The Bionicare® Stimulator System 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 (see clinical studies).

Source page: https://510kreport.com/device/K971437
Methodology: https://510kreport.com/methodology