# K993229: Analgesic Pulser, Model AP-439

- Pathway: 510(k) (Traditional)
- Applicant: Johari Electro-Tech Co.
- Decided: Feb 2, 2001 after 494 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
Longest line of descent: 1 generation back to K964028 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964028: Sys Stim 226, Mettler Electronics Corp. (1997) Summary page 2.
- (no number) Sys stim 206: named in the summary without a submission number
- (no number) Sportx: named in the summary without a submission number

## Most influential descendants
- K024036: Product Line-Combo Stimulator/Sequential Stimulator, Model IF-5000 (2002), 0 descendants of its own

## Indications for use
(A) Interferential current stimulation, Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for; 1 Symptomatic relief and management of chronic (long term) intractable pain. 2 Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions. (B) Electrical Muscle Stimulation (Russian and Galvanic-Interrupted) is indicated for: Relaxation of Muscle spasm. Prevention or Retardation of disuse atrophy. Increasing, local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6. Maintaining or increasing range of motion (C) Galvanic-DC Continuous mode is indicated for:- 1. Relaxation of muscle spasm.

Source page: https://510kreport.com/device/K993229
Methodology: https://510kreport.com/methodology