510(k) · Cleared
ClearedBody Clock Tens N' Tone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Body Clock Health Care, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 20, 2003 as substantially equivalent to K893874 (Altoona Medical Supply, 1989) and 1 other predicate after a 266-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- May 20, 2003
- Review
- 266 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893874 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK893874 Fujitens IiiAltoona Medical Supply · 1989
- This deviceK022849 Body Clock Tens N' ToneBody Clock Health Care, Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893874 | Fujitens Iii | Altoona Medical Supply | 1989 | — |
| 0 (this device) | K022849 | Body Clock Tens N' Tone | Body Clock Health Care, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K893874 | Fujitens IiiSummary page 1…, For Pain Relief and Powered Muscle Stimulator. 1.3 Predicate Device Information: The Body Clock Duo is substantially equivalent to the FUJI TENS 804Slll (K893874) and the Altoona EMS 400 (K913272). Device DescriDtion: The Body Clock Duo has two facilities, enabling it to function as both… | 1989 |
| * | K913272 | EMS/400Summary page 1…d Muscle Stimulator. 1.3 Predicate Device Information: The Body Clock Duo is substantially equivalent to the FUJI TENS 804Slll (K893874) and the Altoona EMS 400 (K913272). Device DescriDtion: The Body Clock Duo has two facilities, enabling it to function as both a TENS unit and as a Powered Muscl… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K893874.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022849: Body Clock Tens N' Tone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022849
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026