# K022849: Body Clock Tens N' Tone

- Pathway: 510(k) (Traditional)
- Applicant: Body Clock Health Care, Ltd.
- Decided: May 20, 2003 after 266 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: 1 generation back to K893874 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893874: Fujitens Iii, Altoona Medical Supply (1989) Summary page 1.
- K913272: EMS/400, Altoona Medical Supply (1991) Summary page 1.

## Indications for use
As a TENS unit, the Body Clock Duo 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. As a Powered Muscle Stimulator unit the Body Clock Duo is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: 1. Relaxation of muscle spasms; 2. Prevention or retardation of disuse atrophy; 3. Increasing local blood circulation; 4. Muscle reeducation; 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K022849
Methodology: https://510kreport.com/methodology