# K091045: Smart Tens, Model: D-BC05T

- Pathway: 510(k) (Traditional)
- Applicant: Body Clock Health Care, Ltd.
- Decided: Dec 18, 2009 after 249 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K111645: FD Tens 2050 or Slide Tens Model FD2050 (2011), 0 descendants of its own

## Indications for use
The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K091045
Methodology: https://510kreport.com/methodology