# K071869: Tens/IF 14

- Pathway: 510(k) (Traditional)
- Applicant: Emsi
- Decided: Mar 7, 2008 after 245 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: 3 generations back to K921441 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060246: Infrex, Johari Digital Healthcare, Ltd. (2006) Summary page 2.
- K021755: Apex Medical Digital Tens TS1211, TS1212, Apex Medical Corp. (2002) Summary page 2.
- K952683: Apex Medical Corp. Portable Interferential Stimulation Device, Wholesale Medical Imports, Inc. (1997) Summary page 2.

## Indications for use
Symptomatic relief of chronic intractable pain Adjunctive treatment for the management of post-traumatic or post-surgical pain

Source page: https://510kreport.com/device/K071869
Methodology: https://510kreport.com/methodology