# K113544: Electronic Pulse Massager Tens Electronic Pulse Massager

- Pathway: 510(k) (Traditional)
- Applicant: Prospera Corporation
- Decided: Jul 27, 2012 after 239 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: 6 generations back to K010782 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102014: Tens Stimulator, Models 2800 and 3000, Koalaty Products, Inc. (2010) Summary page 1.

## Indications for use
Symptomatic relief of acute post traumatic pain, acute post surgical pain, and chronic intractable pain.

Source page: https://510kreport.com/device/K113544
Methodology: https://510kreport.com/methodology