# K020803: Cefar Medical AB Cefar Primo

- Pathway: 510(k) (Traditional)
- Applicant: Cefar Medical AB
- Decided: Jun 10, 2002 after 90 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 K982410 (1998). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982410: SMP-Plus,SX-Plus,SX Model # 49XX Series 9 Volt Tens Device, Rehabilicare, Inc. (1998)

## Most influential descendants
- K032928: Mediphysics Pain Treatment System, Model 1 (2003), 2 descendants of its own
- K070474: Newlife Sciences LLC, Model TMR (2007), 1 descendant of its own
- K202186: TrueRelief Device (2021), 0 descendants of its own

## Indications for use
TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

Source page: https://510kreport.com/device/K020803
Methodology: https://510kreport.com/methodology