Kneehab XP applies muscle and nerve stimulation by using the principles of Neuromuscular Electrical Nerve Stimulation (NMES). NMES is the application of electrical stimulation of the peripheral nervous system to contract a muscle either through the direct activation of the motor neurons in the mixed peripheral nerve, or indirectly through reflex recruitment. Kneehab XP applied brief electrical pulses through skin surface adhesive electrodes. The Kneehab XP conductive garment, type 411 is indicated for muscle re-education of the quadriceps, maintaining or increasing range of motion of the knee joint, prevention or retardation of disuse atrophy in the quadriceps, early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening and increasing local blood circulation.
Device Story
Kneehab XP is a portable, two-channel transcutaneous electrical muscle stimulator (NMES) for quadriceps rehabilitation. System includes a rechargeable control unit, universal thigh garment, and adhesive electrodes. Device uses patented multipath technology to deliver constant current pulses to peripheral nerves, inducing focused quadriceps contractions. Operated by patient or clinician; garment fastens around thigh above kneecap. Control unit plugs into garment socket; powered by 3.6V NiMH battery. Features three 20-minute treatment programs. Internal wiring is over-molded to prevent moisture ingress. Healthcare providers use device to facilitate post-surgical recovery and muscle strengthening. Benefits include improved knee stability, increased range of motion, and prevention of atrophy.
Clinical Evidence
Clinical study titled 'The effectiveness of the Kneehab™ in strengthening the quadriceps of patients in rehabilitation after anterior cruciate ligament reconstruction' was submitted. No specific quantitative metrics (p-values, CIs) are provided in the summary text.
Technological Characteristics
Powered muscle stimulator (21 CFR 890.5850). Two-channel NMES using constant current pulses. Components: rechargeable control unit, conductive garment, adhesive electrodes. Power: 3.6V NiMH battery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10. Over-molded internal connections for moisture protection.
Indications for Use
Indicated for patients requiring quadriceps muscle re-education, maintenance or increase of knee joint range of motion, prevention or retardation of quadriceps disuse atrophy, early post-surgical quadriceps strengthening, improved post-surgical knee stability, and increased local blood circulation.
Regulatory Classification
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
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K083105
This summary is being submitted in accordance with the requirements of 21 CFR 807.92.
# 1. Contact Details -
# JUL 2 4 2009
| Name: | Anne-Marie Keenan |
|------------|-------------------------------------------------------------------------------|
| Address: | Bio-Medical Research Ltd.,<br>Parkmore Business Park, West<br>Galway, Ireland |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774301 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | 15th June 2009 |
## 2. Device Name
| Trade Name of Device: | Kneehab XP Conductive Garment (Type 411) |
|-----------------------|------------------------------------------|
| Common Name: | Muscle Stimulator |
| Classification Name: | Powered Muscle Stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Product Code: | IPF |
# 3. Identification of Equivalent Legally Marketed Device
| 1. Name: | Kneehab, Type 410 |
|---------------|---------------------------|
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No: | K024258, March 2005 |
| 2. Name. | System Shorts, Type 390, Model E20 |
|---------------|------------------------------------|
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No.: | K070142, March 2007 |
#### 4. Description of Device
The Kneehab XP Conductive Garment is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. This technology enables the Kneehab XP Conductive Garment to deliver highly
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focused and accurate quadriceps contractions and operates by using constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses are designed to cause muscular contractions through the application of electrical stimulation to the peripheral nervous system.
The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device. This device cannot be used while being charged.
All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are three treatment programs in total with duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
### 5. Statement of Intended Use/Indications for Use
Kneehab XP applies muscle and nerve stimulation by using the principles of Neuromuscular Electrical Nerve Stimulation (NMES). NMES is the application of electrical stimulation of the peripheral nervous system to contract a muscle either through the direct activation of the motor neurons in the mixed peripheral nerve, or indirectly through reflex recruitment. Kneehab XP applied brief electrical pulses through skin surface adhesive electrodes.
The Kneehab XP conductive garment, type 411 is indicated for muscle re-education of the quadriceps, maintaining or increasing range of motion of the knee joint, prevention or retardation of disuse atrophy in the quadriceps, early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening and increasing local blood circulation.
#### 6. Technological Characteristics
There are no new technological characteristics that could affect safety or effectiveness of the Kneebab XP Conductive Garment, Type 411 device. Substantial Equivalence has been demonstrated as part this 510k submission.
.
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# 7. Clinical and Non-Clinical Tests
Bio-Medical Research Ltd. ("BMR") has over 30 years experience in the research, design, manufacture and marketing of medical grade products for both muscle strengthening and pain relief. BMR has two divisions - Slendertone, which develops and markets a range of consumer health and fitness products and Neurotech, which provides a range of neuromuscular stimulators for pain management and rehabilitation. Bio-Medical Research Ltd. complies with 21 CFR 820 and is registered to I.S. EN ISO 13485:2003 Medical Device Quality Management System for the design, manufacture and distribution of electro-medical devices.
Kneehab XP Conductive Garment complies with the following electrical safety and EMC international standards:
- · ロ IEC 60601-1 (1998) + A1: 1991, A2: 1995, Medical Electrical Equipment Part 1: General Requirements for Safety
- D IEC 60601-1-2 (2001), Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility Requirements & Tests.
- D IEC 60601-2-10 (1987) + A1: 2001 Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
A clinical study, "The effectiveness of the Kneehab™ in strengthening the quadriceps of patients in rehabilitation after anterior cruciate ligament reconstruction'', has been submitted as part of this 510k premarket notification.
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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three talons, representing service, science, and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Bio-Medical Research, Ltd. % Ms. Anne-Marie Keenan Parkmore Business Park West Galway, Ireland
JUL 8 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K083105
Trade/Device Name: Kneehab XP Conductive Garment, Type 411 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: July 15, 2009 Received: July 21, 2009
Dear Ms. Keenan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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#### Page 2 - Ms. Anne-Marie Keenan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known):
Device Name:
Kneehab XP Conductive Garment, Type 411
Indications for Use:
# Muscle re-education of the quadriceps,
모 Maintaining or increase range of motion of the knee joint,
전 Prevention or retardation of disuse atrophy in the quadriceps,
프 Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening,
Increasing local blood circulation. 필
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vannell, Vane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083105
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
