# K973979: Multi-Stim Tens, AP-101081T

- 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.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062547: Quadra Bloc Tens, Model 101 (2007), 1 descendant of its own
- K102278: Quadra Bloc Tens Plus (2011), 0 descendants of its own

## Indications for use
INDICATIONS: Transcutaneous Electrical Nerve Stimulatior (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as adjunctive treatment in the management of posi surgical and post traumatic acute pain problens. CONTRAINDICATIONS: TENS devices can affect the operation of demand type cardiac pacemakers. TENS is not recommended for patients with know heart disecase without physical evaluation of possible risk. Do not stimulate over the eyes or carotid sinus nerves. Do not apply TENS for undiagnosed pain syndromes until the ctiology is established.

Source page: https://510kreport.com/device/K973979
Methodology: https://510kreport.com/methodology