510(k) · Cleared
ClearedWinner CM4 Combination Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rich-Mar Corp. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Oct 25, 2001 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 25, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: 1) Relief of pain 2) Muscle Spasms 3) Joint contractures But NOT for the treatment of malignancies Microcurrent output is indicated for the following conditions: 1) Symptomatic relief of chronic, intractable pain. 2) Management of pain associated with posi-traumatic or posi-operative conditions. This device is indicated for the following conditions…
Read the full statement (146 words)
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:
1) Relief of pain
2) Muscle Spasms
3) Joint contractures
But NOT for the treatment of malignancies
Microcurrent output is indicated for the following conditions:
1) Symptomatic relief of chronic, intractable pain.
2) Management of pain associated with posi-traumatic or posi-operative conditions.
This device is indicated for the following conditions:
1) Relaxation of muscle spasms.
2) Prevention or retardation of disuse atrophy.
3) Increasing local blood circulation.
4) Muscle re-education.
5) Maintaining or increasing range of motion.
6) Immediate post-surgical stimulation of calf muscles 1o prevent venous thrombosis.
Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
(Quadpolar Interferential and Microamperage Pulsed Current)
1) Symptomatic relief of chronic, intractable pain,
2) Management of pain associated with post-traumatic or posi-operative conditions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012848: Winner CM4 Combination Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012848
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026