510(k) · Cleared
ClearedKneehab XP
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 Aug 3, 2011 as substantially equivalent to K083105 (Bio-Medical Research, Ltd., 2009) and 4 other predicates after a 177-day review. Its family tree reaches back 4 generations to 2001. 9 later devices descend from it.
- Decided
- Aug 3, 2011
- Review
- 177 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K010335 (2001). 17 ancestors in all, the oldest K926510 (1993). 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 3 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 2 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 1 generation backK083105 Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009
- This deviceK110350 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 · 2 generations on · 1 of its ownK212832 TimeWaver FrequencyTimewaver Production GmbH · 2021
- Descendant · 3 generations on · 1 of its ownK210674 Shoulder PacemakerNcs Lab Srl · 2021
- Descendant · 3 generations on · 1 of its ownK210604 Intellihab SystemCymedica Orthopedics, Inc. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K212832TimeWaver FrequencyTimewaver Production GmbH · 2021 · 2 generations on1descendant
- K210674Shoulder PacemakerNcs Lab Srl · 2021 · 3 generations on1descendant
- K210604Intellihab SystemCymedica Orthopedics, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −3 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −2 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −1 | K083105 | Kneehab XP Conductive Garment, Type 411 | Bio-Medical Research, Ltd. | 2009 | — |
| 0 (this device) | 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 | — |
| +2 | K212832 | TimeWaver Frequency | Timewaver Production GmbH | 2021 | — |
| +3 | K210674 | Shoulder Pacemaker | Ncs Lab Srl | 2021 | — |
| +3 | K210604 | Intellihab System | Cymedica Orthopedics, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K083105 | Kneehab XP Conductive Garment, Type 411Summary page 1…, NYN Device Class: 2 3. Identification of Equivalent Legally Marketed Device 5 10O(k) Numjber: K083 105 Manufacturer: Rio-Medical Research Ltd. Trade Name: Kneehab… | 2009 |
| * | K082011 | Medistim XP, Type 281 and Meditens XP, Type 458Summary page 2…, P. K. McDonnell. C. 1im~gue. P. Mc~rath Registered iii Ireland No. 152947 5 10O(k) Number: K082011I Manufacturer: Bio-Medical Research Ltd. Trade Name: MediStimi XP, Type 281 5 10(k) Numb… | 2008 |
| * | K061516 | Staodyn Max Preset, Model 4470Summary page 2…K082011 Manufacturer: Rio-Medical Research Ltd. Trade Name: MediTens XP, Type 458 5 10(k) Number: K061516 Manufacturer: Conipex Technologies, Inc Trade Name: Staodyn Max Preset 5 10(k) Number:… | 2007 |
| * | K021100 | 300 PV Complete Electrotherapy SystemSummary page 5…9 Staodyn Max 300 PY Complete Bionicare® Stimulator : + .| Conductive Garment R Electrotherapy System_ | System 510k Number: Ki10350 ¢ - K083105 K082011 K082011 K061516 K021100 K971437 Intended Use The Kneehab XP is [ The Knechab XPis | The MediTens XP i | The Kneehab XP is [ The Knechash XP o is | The… | 2002 |
| * | K971437 | Bionicare Stimulator System. Model Bio-1000Summary page 2…K(021 100 Manufacturer: Empi Trade Name: 300 PV Complete Electrotherapy System 5 10(k) Number: K971437 Manufacturer: BioniCare Medical Technologies Trade Name: Bionicare® Stimulator Systemn… | 1997 |
What descends from it? (9)
2 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K150413 (Cymedica Orthopedics, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K083105.
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. 2011, 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 Kneehab XP, Type 412/421, Indications for use are as follows: In NMES mode (Programs 1-6) the Kneehab XP is intended to: * Maintain or increase the range of motion. * Prevention or retardation of disuse atrophy * Re-educate muscles Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening * Relax muscle spasms * Increase blood circulation In TENS Mode (Programs 7 - 9) the Kneehab XP…
Read the full statement (134 words)
The Kneehab XP, Type 412/421, Indications for use are as follows:
In NMES mode (Programs 1-6) the Kneehab XP is intended to:
* Maintain or increase the range of motion.
* Prevention or retardation of disuse atrophy
* Re-educate muscles
Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
* Relax muscle spasms
* Increase blood circulation
In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to:
* Provide symptomatic relief and management of chronic, intractable pain
* Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain
* Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis
* Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110350: Kneehab XP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110350
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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