# K973978: Micro II Microcurrent Tens

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: Jul 29, 1998 after 282 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
This device is restricted to sale or use by or on the order of a physician licensed in the state in which he or she is practicing. It is to be used solely for the symptomatic relief of chronic intractable pain. CONTRAINDICATIONS: 1. TENS electrodes must be placed in such a position so as to pass electrical current into the carotid gland area. 2. TENS must not be prescribed to patients who are using a demand type cardic pacemaker. 3. TENS electrodes must not be placed so as to pass current transcerebrally through the head. 4. TENS application must not be recommended before pain syndromes are diagnosed, and not before an appropriate etiology has been established.

Source page: https://510kreport.com/device/K973978
Methodology: https://510kreport.com/methodology