# K994265: Medisana Digital Tens

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics Limited
- Decided: Jul 6, 2000 after 202 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073008: KFH Energy, Model: E1 (2008), 0 descendants of its own

## Indications for use
TENS stands for Transcutaneous Electrical Nerve Stimulation and is a non-invasive and drug-free pain management unit. The TENS system is designed for the treatment of pain - chronic, acute or post-operative pain.

Source page: https://510kreport.com/device/K994265
Methodology: https://510kreport.com/methodology