510(k) · Cleared
ClearedBasba E-Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Basba, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Nov 18, 2004 as substantially equivalent to K021755 (Apex Medical Corp., 2002) and 1 other predicate after a 198-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Nov 18, 2004
- Review
- 198 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021755 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK021755 Apex Medical Digital Tens TS1211, TS1212Apex Medical Corp. · 2002
- This deviceK041172 Basba E-MachineBasba, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021755 | Apex Medical Digital Tens TS1211, TS1212 | Apex Medical Corp. | 2002 | — |
| 0 (this device) | K041172 | Basba E-Machine | Basba, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K021755 | Apex Medical Digital Tens TS1211, TS1212Summary page 1…rical Nerve Stimulator (TENS) devices currently in commercial distribution such as the Apex Medical Corporation's Apex Medical Digital TENS TS1211, TS1212 (K021755) and Biomedical Life Systems, Inc. Electro-Nerve Stimulator TENS, Model BmlsO3-5 (K033455). IV. Intended Use of the Dev… | 2002 |
| * | K033455 | Electro-Nerve Stimulator Tens, Model BMLS03-5Summary page 1…x Medical Corporation's Apex Medical Digital TENS TS1211, TS1212 (K021755) and Biomedical Life Systems, Inc. Electro-Nerve Stimulator TENS, Model BmlsO3-5 (K033455). IV. Intended Use of the Device The Basba E-Machine is intended for use as a symptomatic relief and management… | 2004 |
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.
- 5 other devices also cite its predicate K021755.
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?
The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041172: Basba E-Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041172
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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