# K013507: Cosmo Tens PF-990 Mini Digital Wireless Patch

- Pathway: 510(k) (Traditional)
- Applicant: Cosmo Health, Inc.
- Decided: Jan 25, 2002 after 95 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.
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 COSMO TENS PF-990 Mini Digital Wireless Patch, a Transcutaneous Electrical Nerve Stimulator is indicated only for symptomatic relief of chronic intractable pain, posttraumatic and post-surgical pain relief. COSMO TENS PF-990 is indicated to be well attached to the skin by its patch before being turned on. It provides low frequency therapy that makes use of weak electrical currents applied to the body to directly stimulate nerve pathways.

Source page: https://510kreport.com/device/K013507
Methodology: https://510kreport.com/methodology