HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P
K102236 · D.T. Davis Enterprises Ltd. T/A Hovertech Int'L · INK · Nov 18, 2010 · Physical Medicine
Device Facts
Record ID
K102236
Device Name
HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P
Applicant
D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
Product Code
INK · Physical Medicine
Decision Date
Nov 18, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.3690
Device Class
Class 2
Indications for Use
This device is a motorized device intended for medical purposes to assist in the transport of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles.
Device Story
Battery-powered motorized patient transport device; aids caregivers in maneuvering patients within care facilities. Supports patients in seated or supine positions during examinations, physical therapy, and clinical activities. Includes supports for fluid infusion equipment. Operated by caregivers in clinical settings. Enhances patient comfort and caregiver access via adjustability. Benefits include reduced physical strain on caregivers during patient transport and improved patient positioning for clinical care.
Clinical Evidence
Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-38, UL 2601-1, and CAN/CSA C22.2 No. 601.1-M90. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Battery-powered motorized wheeled stretcher. Materials tested for biocompatibility per ISO 10993-5 and 10993-10. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-38 (hospital bed safety).
Indications for Use
Indicated for patients requiring assistance during transfer to and from beds, chairs, treatment facilities, wheelchairs, or transport vehicles within clinical environments.
Regulatory Classification
Identification
A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).
Special Controls
(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable;
(9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device;
(10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and
(11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.
Predicate Devices
Transmotion Medical Model TMM6 Power Drive Chair
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the text "K102236" at the top. Below that is the logo for Hovertech International. The logo includes a stylized graphic of curved lines, with the text "HOVERTECH" in bold, uppercase letters. Below that, the word "International" is written in a smaller, non-bold font.
## "510/k) SUMMARY" as required by section 807.92(c)
Submitter Information:
D.T. Davis Enterprises, LTD T/A HoverTech International 513 S. Clewell Street Bethlehem, PA 18015 Phone: (610)-694-9600 Fax: (610)694-9601
NOV 1 9 2010
Susan Pavelko Quality Manager D. T. Davis Enterprises, LTD
Date Summary Prepared:
Trade Name:
Contact Person:
Common Name:
Classification Name:
March 17, 2010
HoverTech International® Transformer
Stretcher, Wheeled, Powered
Powered wheeled stretcher (21CFR 890.3690, Product Code INK)
Legally Marketed Device: Transmotion Medical Model TMM6 Power Drive Chair
Device Description: The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.
Intended use: This device is a motorized device intended for medical purposes to assist in the transport of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles. The FDA has classified the device as a Class II device.
513 S. Clewell Street Bethlehem, PA 18015
Phone 800.471.2776 Fax 610.694.9601
www.HoverMatt.com info@HoverMall.c
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Image /page/1/Picture/0 description: The image shows the logo for Hovertech International. The logo consists of a stylized graphic of curved lines, resembling air currents or waves, on the left side. To the right of the graphic is the company name, "HOVERTECH," in bold, uppercase letters. Below "HOVERTECH" is the word "International" in a smaller, regular font.
HoverMatt.com
Device Comparison: The HoverTech International® Transformer is substantially equivalent to the Transmotion Medical Model TMM6 Power Drive Chair in function and intended use. Any minor differences described in the submission between the HoverTech International® Transformer and that of the predicate devices does not raise any new issues of safety or effectiveness. The intended use, basic technology, and performance characteristics of the system are the same.
The subject device is intended to be used in any clinical environment where patient care is administered. Health facilities ordinarily used stretchers for patient treatment, recovery and for transportation to and from treatment modalities, i.e. physical therapy, diagnostic radiology, etc.
The labels and labeling (Operator's and Maintenance Manuals) provide information for the safe operation by the caregiver/user and the intended operation features.
No performance standards or special controls have been promulgated for powered patient transport devices under sections 513 and 514 of the FD&C Act.
Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications. These reports are maintained as required by 21 CFR 820, Quality Systems Regulations.
An assessment of known and reasonable hazards has been conducted to ensure that any An associated with the device as of the date of product release is as low as reasonably nossible. Design review has been conducted by a cross-functional team, including but not limited to regulatory, quality, engineering and manufacturing.
5-2
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HOVERTECH
International
The device will comply with the following voluntary standards:
- > IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988 (General), Amendment 1, 1991-11, Amendment 2, 2 1995-03
- > IEC 60601-1-2. (First Edition, 1993-04), Medical Equipment -- Part 1: General Requirements for Safety; Electromagnetic Compatibility -Requirements and Tests (General)
- > IEC 60601-2-38 Issue: 1996/10/01 Ed: 1 Medical Electrical Equipment -Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital Beds; Amd. 1: 12-1999- Applicable parts only (loading and pinch points)
- > UL 2601-1 (2nd Edition) Standard for Medical Electrical Equipment, Part 1: General Reguirements for Safety - Issued: 2003/04/24 Edition 1, Revision: 2006/04/26
- > CAN/CSA C22.2 No. 601.1-M90 Standard for Medical Equipment
- > ISO 10993-5: 1999, Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility)
- > ISO 10933-10: 2002, Biological evaluation of medical devices- Part 10: Tests for irritation and Sensitization pp. 6 - 10, 21 (Biocompatibility)
- > ISO 10933-10: 2002, Biological evaluation of medical devices- Part 10: Tests for irritation and delayed type hypersensitivity pp. 18-20. (Biocompatibility)
The Transformer and predicate powered patient transport included in this submission are substantially equivalent.
HoverMatt.com
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
D.T. Davis Enterprises, LTD % HoverTech International Ms. Susan Pavelko Quality Manager 513 South Clewell Street Bethlehem, Pennsylvania 18015
NOV 1 9 2010
Re: K102236
Trade/Device Name: The HoverTech International HoverTrans™ Transformer Regulation Number: 21 CFR 890.3690 Regulation Name: Powered wheeled stretcher Regulatory Class: Class II Product Code: INK Dated: August 5, 2010 Received: August 25, 2010
Dear Ms. Pavelko:
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
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Page 2 - Ms. Susan Pavelko
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.
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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.
Sincerely vours.
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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K10236.
## Section 4:
## Indications for Use
NOV 18 2 12
510(k) Number (if known):
Device Name: The HoverTech International HoverTrans™ Transformer
Indications For Use: The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
Prescription Use (Part 21 CFR 801 Subpart D)
. (*--
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Counter Use
(21 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102236
Page 1 of 1
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.
