Medline's Limb holders are intended to be utilized as a patient safety device when limited movement of the limb is deemed necessary. The limb holders are all of the same basic design, some with different linings on the cuff, others utilize buckles, hook and loop closures ("velcro") or D-rings. They may be used either at the wrist or ankle and may tie to the bed frame or wheelchair.
Device Story
Limb holders function as physical restraints to limit patient movement; applied to wrists or ankles; secured to bed frames or wheelchairs. Designs include various cuff linings (synthetic fur, cotton, orthopedic felt, foam) and closure mechanisms (buckles, hook-and-loop, D-rings). Used in clinical settings under supervision of medical personnel. Benefits include preventing accidental discontinuation of life-support or medical interventions and managing agitated patients. Risks include chafing, nerve damage, circulatory impairment, and strangulation if improperly applied or monitored.
Clinical Evidence
No clinical trials performed. Evidence based on literature review of thirteen articles regarding safety and effectiveness of protective restraints. Literature identifies potential complications including nerve damage, circulatory impairment, and strangulation, emphasizing the necessity of proper patient selection, application, and monitoring by healthcare personnel.
Technological Characteristics
Materials include cotton, nylon, synthetic fur, orthopedic felt, and foam. Closure mechanisms include corset buckles, hook-and-loop (velcro), and metal D-rings. Devices are manual, non-powered, and available in washable or single-patient-use configurations.
Indications for Use
Indicated for patients requiring temporary limb movement restriction to prevent interference with medical interventions or to manage agitation. Contraindicated for patients where physical restraint is inappropriate. Use requires advice of a physician or trained, licensed healthcare professional.
Regulatory Classification
Identification
A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
Reference Devices
Physical Restraints: An FDA Update, American Journal of Nursing (1992)
Potential Hazards With Protective Restraint Devices; FDA Medical Alert (1991)
The Misuse of Physical Restraints in the Confused Patient (1986)
Federal Register/Vol. 57, No. 119 (1992)
Potential Hazards with Physical Restraint Devices; FDA Safety Alert (1992)
Restraint and Seclusion; Journal of Psychosocial Nursing (1985)
Submission Summary (Full Text)
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MEDLINE
Medline Industries, Inc.
One Medline Place
Mundelein, Illinois 60060.4486
1.847.949.3109
1.800.950.0128
Fax 1.847.949.2643
Corporate Quality Assurance/Regulatory Affairs
# SAFETY AND EFFECTIVENESS SUMMARY
K 963578
Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
Phone #: (847) 949-2639
Fax #: (847) 949-2643
Lara N. Simmons
Corporate Regulatory Affairs Manager
OCT 29 1996
August 20, 1996
Device Name: Protective Restraint, Limb Holder
Wheelchair Accessory, Limb Holder
Proprietary: Medline Economy Limb Holder, Medline Deluxe Limb
Holder, Medline Cinch-Type Limb Holder, Medline
Padded Limb Holder, Medline Adjustable Limb
Holder, Medline Quick Control Limb Holder, Medline
Modified Cinch-Type Limb Holder.
Common: Limb Restraint
These devices have been legally marketed prior to the date of this submission. The intended use and claims, technological features, materials and physical and mechanical specifications have not been changed.
# 1.0 General Description
Medline's Limb holders are intended to be utilized as a patient safety device when limited movement of the limb is deemed necessary. The limb holders are all of the same basic design, some with different linings on the cuff, others utilize buckles, hook and loop closures ("velcro") or D-rings. They may be used either at the wrist or ankle and may tie to the bed frame or wheelchair.
The various types of limb holders are discussed as follows:
1. Deluxe Limb Holder - Lined with synthetic fur to minimize chafe and irritation. Hook and loop closure to help prevent tightening or loosening of cuff. Straps adjust via sewn in loops. May tie to bed frame or wheelchair frame. These limb holders are available in either cotton or nylon. Reference Attachment A for a picture of this device. Item is washable.
2. Padded Limb Holder - Lined with synthetic fur to minimize chafe and irritation. Cuff adjusts using a corset buckle that helps prevent tightening or loosening of cuff. Belts
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may be detachable or non-detachable at cuff, and adjust via corset buckles. Reference Attachment A for a picture of this device. Item is washable.
3. Quick Control Limb Holder - Lined with synthetic fur to minimize chafe and irritation. Cuff adjusts using a hook and loop closure with two adjustment rings. Reference Attachment A for a picture of this device. Item is washable.
4. Adjustable Limb Holder - Lined with cotton to help minimize chafe and irritation. straps adjust via sewn on loops. Reference Attachment A for a picture of this device. Item is washable. Cuff backing may be Cotton Flannel or Nylon.
5. Cinch-Type Limb Holder - Lined with one-piece foam to minimize chafe and irritation. Hook and loop closure tab will adhere anywhere on the foam backing. Straps adjust via metal "D" rings. Reference Attachment A for a picture of this device. Item may be washed or discarded.
6. Modified Cinch-Type Limb Holder - Lined with one-piece foam to minimize chafe and irritation. Hook and loop closure tab will adhere anywhere on the foam backing. Straps adjust via metal "D" rings. This item differs from the Cinch-Type Limb Holder in that the wrist strap is independent of the anchor strap. Reference Attachment A for a picture of this device. Item may be washed or discarded.
7. Economy Limb Holder - Cuff is made of orthopedic felt. Straps adjust using corset buckles. Reference Attachment A for a picture of this device. Item may be washed or discarded.
8.0 Single Patient Use Limb Holder - Cuff is made of foam that closes with a hook and loop tab with a nylon "D" ring. This item is the same in design as our Cinch-Type Limb Holder but is not washable and is labeled for single patient use only.
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A reasonable search of all information known or otherwise presently available to Medline Industries, Inc. has been conducted. Such a search is defined as examining articles in medical literature, FDA literature, and company documents concerning safety and effectiveness information for safety restraints. Following is a summary of and citation to the safety and effectiveness data found in that search.
Specific safety and effectiveness data outlined in the literature include actual as well as potential complications which may occur and are summarized as follows:
Emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, and strangulation attributed to incorrect supervision, handling or application of protective restraint devices by medical or paramedical personnel. These incidences seem to be the result of inappropriate patient selection (physically restraining a patient for whom physical restraint is contraindicated), incorrect restraint selection, errors in correctly applying the device, and/or inadequate monitory of patients when restrained.
When used correctly and for indicated circumstances, protective restrains provide benefits to many patients, such as precluding patients with temporary medical related cognitive deficits from impairing the resolution of their physical problems by involuntarily discontinuing life-support or other needed medical interventions, temporarily reducing the mobility of agitated patients, or limiting the movement of a restrained limb to a desired range or limit.
Medline Industries, Inc. offers a variety of additional materials to help insure the safe and proper use of it's patient safety products, including posters and videos. Medline Industries, Inc. stresses the importance of patient monitoring, and that these products should only be used upon advice of a physician or other trained, licensed healthcare professional.
A total of thirteen articles were reviewed for this 510(k) submission. The articles listed in the citation contained pertinent data for establishing the safety and efficacy of protective restraints.
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# CITATION
Physical Restraints: An FDA Update, American Journal of Nursing From FDA Nurses 1992; 74: November 1992, Mary D. Weick, RN, MSN.
Potential Hazards With Protective Restraint Devices; FDA Medical Alert, dated November 14, 1991; MDA91-3
The Misuse of Physical Restraints in the Confused Patient; This paper was presented by Ms. Barbara Fitgerald, Ward Sister, Geriatric Unit, St. James Hospital Dublin at the INO Nursing Association for the Elderly Day Conference in April, 1986.
Federal Register/Vol. 57, No. 119/Friday, June 19, 1992/ Proposed Rules
Potential Hazards with Physical Restraint Devices; FDA Safety Alert, dated July 15, 1992
Restraint and Seclusion; Journal of Psychosocial Nursing, June 1985, Vol. 23, No. 6, Janice M. Roper, RN, MS, Adam Courtts, MS Janet Sather, RN, and Rosella Taylor, RN.
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Learn the FDA Browser
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.
