# K021518: Paindoc

- Pathway: 510(k) (Special)
- Applicant: Advanced Neuromodulation Systems
- Decided: Jun 6, 2002 after 27 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The PainDoc is intended to assist clinicians and patients in determining the optimum performance while automatically logging procedures data. PainDoc also allows the patient to assist in the optimization of performance by leading them through a series of combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.

Source page: https://510kreport.com/device/K021518
Methodology: https://510kreport.com/methodology