510(k) · Cleared
ClearedJoint Stim, Model 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pain Management Technologies · NYN Stimulator, Electrical, Transcutaneous, For Arthritis
Cleared on Jul 30, 2008 as substantially equivalent to K030332 (Bionicare Medical Technologies, Inc., 2003) and 1 other predicate after a 240-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Jul 30, 2008
- Review
- 240 days
- Class
- Class II
- Product code
- NYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971437 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK971437 Bionicare Stimulator System. Model Bio-1000Murray Electronics · 1997
- 2 generations backK983228 Bionicare Stimilator System, Model Bio-1000Murray Electronics · 1999
- 1 generation backK052625 Bionicare Stimulator System, Model Bio-1000Bionicare Medical Technologies, Inc. · 2005
- This deviceK073386 Joint Stim, Model 1000Pain Management Technologies · 2008
- Descendant · cites it directly · 0 of its ownK111557 X-ForceSeven Seas Distribtion and Manufacturing, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K111557X-ForceSeven Seas Distribtion and Manufacturing, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971437 | Bionicare Stimulator System. Model Bio-1000 | Murray Electronics | 1997 | — |
| −2 | K983228 | Bionicare Stimilator System, Model Bio-1000 | Murray Electronics | 1999 | — |
| −1 | K052625 | Bionicare Stimulator System, Model Bio-1000 | Bionicare Medical Technologies, Inc. | 2005 | — |
| 0 (this device) | K073386 | Joint Stim, Model 1000 | Pain Management Technologies | 2008 | — |
| +1 | K111557 | X-Force | Seven Seas Distribtion and Manufacturing, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 NYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K030332 | Modification to Bionicare Stimulator System, Model Bio-1000Summary page 1…t Code: NYN Regulation number 21 CFR 882.5890 Predicate Devices: The Bionicare Stimulator, Model Bio 1000 - K030332 and the K052625 4J?~~, Device Description: The… | 2003 |
| * | K052625 | Bionicare Stimulator System, Model Bio-1000Summary page 1…lation number 21 CFR 882.5890 Predicate Devices: The Bionicare Stimulator, Model Bio 1000 - K030332 and the K052625 4J?~~, Device Description: The J-Stim 1000 consists of electrodes, the lead wires,… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111557 | X-Force | 2011 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K111557 (Seven Seas Distribtion and Manufacturing, LLC, 2011) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K030332.
How does its category compare?
All NYN devicesNYN Stimulator, Electrical, Transcutaneous, For Arthritis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NYN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NYN
Too few NYN 510(k)s in any year since 2007 to give a median.
Recalls per year · NYN
No recall names NYN since 2007.
Adverse event reports per year · NYN
1in 2012
MAUDE reports naming product code NYN, 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 | 1 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The J-Sirn I 000 'TM ' external, nonrinvaisive,. non-narcotic, electrotherapy system is indicated for use as an adjamnctive therapy in reducing the level of pain and symptoms associated with osteoarahritis of the knee and for overall improvement of the knee.
The i-Stim I000 TM is also indicated -for use as an adjunctive therapy in reducing the level of pain, and _tiffness associated with pain, friom rheumatoid arthritis of the hand.
These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to ohtain this product, The product can be used in the home or clinic by all patients in need.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073386: Joint Stim, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073386
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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