510(k) · Cleared
ClearedProstim 1000/2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Protech, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 7, 2008 as substantially equivalent to K061476 (Biomedical Life Systems, Inc., 2006) and 2 other predicates after a 62-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Feb 7, 2008
- Review
- 62 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921441 (1992). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
- 2 generations backK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
- 1 generation backK060246 InfrexJohari Digital Healthcare, Ltd. · 2006
- This deviceK073438 Prostim 1000/2000Bio Protech, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921441 | Interferential Stimulator Model Inf 4150/a | Biomedical Life Systems, Inc. | 1992 | — |
| −2 | K952683 | Apex Medical Corp. Portable Interferential Stimulation Device | Wholesale Medical Imports, Inc. | 1997 | — |
| −1 | K060246 | Infrex | Johari Digital Healthcare, Ltd. | 2006 | — |
| 0 (this device) | K073438 | Prostim 1000/2000 | Bio Protech, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K061476 | Electro-Nerve Stimulator Tens, Model BMLS06-1Summary page 1…arketed Device: Company Product 510(k)# Biomedical Life Systems, Inc. Electro-Nerve Stimulator TENS K06 1476 Theratech, Inc. TfLech Model 200E+TENS K(021436 Johari Digital Healthcare Ltd. Infrex… | 2006 |
| * | K021436 | Ttech Model 200E + Tens DeviceSummary page 1…510(k)# Biomedical Life Systems, Inc. Electro-Nerve Stimulator TENS K06 1476 Theratech, Inc. TfLech Model 200E+TENS K(021436 Johari Digital Healthcare Ltd. Infrex K(060246 Description: The PROSTIM 1000/2000 arc battery… | 2002 |
| * | K060246 | InfrexSummary page 1…K06 1476 Theratech, Inc. TfLech Model 200E+TENS K(021436 Johari Digital Healthcare Ltd. Infrex K(060246 Description: The PROSTIM 1000/2000 arc battery operated TENS units for pain control. User driven the units feature a wide array… | 2006 |
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 7 ancestors has a 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. 2008, this device’s year, is highlighted.
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 PROSTIM 1000/2000 is used for the symptomatic relief and management of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain.
This is a prescription device and should be used under continued medical supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073438 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073438: Prostim 1000/2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073438
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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