510(k) · Cleared
ClearedMedistim XP, Type 281 and Meditens XP, Type 458
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Nov 28, 2008 as substantially equivalent to K014020 (Bio-Medical Research, Ltd., 2002) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 2002. 14 later devices descend from it.
- Decided
- Nov 28, 2008
- Review
- 136 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K014020 (2002). 2 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK014020 NT Meditens Plus, Type 290Bio-Medical Research, Ltd. · 2002
- This deviceK082011 Medistim XP, Type 281 and Meditens XP, Type 458Bio-Medical Research, Ltd. · 2008
- Descendant · cites it directly · 9 of its ownK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- Descendant · cites it directly · 7 of its ownK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK193275 Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2020
- Descendant · 2 generations on · 1 of its ownK212832 TimeWaver FrequencyTimewaver Production GmbH · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K110350Kneehab XPBio-Medical Research, Ltd. · 2011 · cites it directly9descendants
- K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc. · 2015 · cites it directly7descendants
- K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016 · 2 generations on4descendants
- K193275Nerve and Muscle StimulatorShenzhen Xft Medical Limited · 2020 · cites it directly2descendants
- K212832TimeWaver FrequencyTimewaver Production GmbH · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K014020 | NT Meditens Plus, Type 290 | Bio-Medical Research, Ltd. | 2002 | — |
| 0 (this device) | K082011 | Medistim XP, Type 281 and Meditens XP, Type 458 | Bio-Medical Research, Ltd. | 2008 | — |
| +1 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| +1 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| +2 | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| +1 | K193275 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020 | — |
| +2 | K212832 | TimeWaver Frequency | Timewaver Production GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K014020 | NT Meditens Plus, Type 290Summary page 1…Equivalent Device: Meditens Plus, Type 290 Manufacturer: Bio-Medical Research Ltd 510O(k) No: K01 4020, July 2002 Trade Name: Medistim XP, Type 281 (Device 2) Common Name: Musc… | 2002 |
| * | K014019 | Neurotech Medistim Plus, Type 291Summary page 1…Equivalent Device: Medistim Plus, Type 291 Manufacturer: Bio-Medical Research Ltd 5 10O(k) No: K014019, July 2002 Directors: T. Kirwan (Chairman), Dr. P. A. Smith (Managing), P.K. McDonnell, C. Minogue, P. McGrath.… | 2002 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K110350 (Bio-Medical Research, Ltd., 2011) has gone furthest, with 9 descendants of its own.
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 symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and post-traumatic pain. The device has no curative value and should only be used in conjunction with medical supervision. Neuromuscular Electrical Stimulation (NMES) for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate…
Read the full statement (96 words)
The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and post-traumatic pain. The device has no curative value and should only be used in conjunction with medical supervision.
Neuromuscular Electrical Stimulation (NMES) for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
Transcutaneous Electrical Nerve Stimulation (TENS) for an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082011: Medistim XP, Type 281 and Meditens XP, Type 458.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082011
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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