# K961050: Reliefband Tens Unit (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Maven Labs, Inc.
- Decided: Aug 1, 1997 after 540 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.
21 later devices descend from it; 1 cites it directly.
0 of 22 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
- K980333: Reliefband (1998), 20 descendants of its own
- K982436: Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R (1998), 19 descendants of its own
- K994387: Reliefband NST Device, Model WB-2L, WB-6L, WB-RL (2000), 18 descendants of its own
- K020180: Reliefband Device, Models RB-DL, RB-EL, RB-RL (2002), 17 descendants of its own
- K033268: Sea-Band (2004), 10 descendants of its own

## Indications for use
To reduce the frequency of nausea and vomiting due to chemotherapy, motion sickness, and pregnancy.

Source page: https://510kreport.com/device/K961050
Methodology: https://510kreport.com/methodology