# K042107: Tung FU Airmate Tens, Vitality Mode, TF-DT001

- Pathway: 510(k) (Traditional)
- Applicant: Tung FU Electric Co., Ltd.
- Decided: Mar 9, 2005 after 217 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
Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. Clinical settings: should be used under the instruction or prescriptions by qualified health professionals prior to the applications of the device at home or hospital facilities.

Source page: https://510kreport.com/device/K042107
Methodology: https://510kreport.com/methodology