(102 days)
Not Found
No
The device description and performance studies focus on mechanical and structural aspects of a manual wheelchair, with no mention of AI or ML.
No
The device is described as a means of mobility; it does not mention any therapeutic use or medical treatment.
No
The device is a manual wheelchair intended for mobility. It is not designed to diagnose any medical condition.
No
The device description explicitly states it is a "composite based mechanical, manually operated, wheelchair" and lists physical components like frame, wheels, and brakes. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Bowhead ERA Wheelchair is a mechanical, manually operated wheelchair used for mobility. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is for mobility for individuals restricted to a sitting position. This is a physical aid, not a diagnostic tool.
The provided information clearly describes a physical mobility device, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Bowhead ERA Wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position.
Product codes
IOR
Device Description
The Bowhead ERA Wheelchairs are composite based mechanical, manually operated, wheelchairs intended to be used as a means of mobility for adults restricted to a sitting position. Using the push ring on the rear wheels, users can self-propel themselves forward or backwards. The chairs are designed for riding over various indoor and outdoor surfaces.
The Bowhead ERA Wheelchairs include four (4) mechanical wheelchair models with each model containing slightly different design features. Each wheelchair is provided assembled with a sling backrest, seat, seat post, brakes, frame, rear wheels, and casters. The overall length, width and height, backrest angle, COG, wheelbase, and seat width and height are adjustable ensuring comfort for the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were performed to support substantial equivalence:
- . RESNA WC-1:2019, Section 1: Determination of static stability
- RESNA WC-1:2019, Section 3: Determination of effectiveness of brakes .
- . RESNA WC-1:2019, Section 5: Determination of overall dimensions, mass and maneuvering space
- RESNA WC-1:2019, Section 7: Measurement of seating and wheel dimensions
- . RESNA WC-1:2019, Section 8: Requirements and test methods for static, impact and fatigue strengths
- RESNA WC-1:2019, Section 13: Determination of coefficient of friction of test surfaces ●
- . Flammability testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
January 10, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Bowhead Design Corp. % Roshana Ahmed Principal Consultant Ouaras. LLC 2101 Camino Rey Fullerton, California 92833
Re: K243111
Trade/Device Name: Bowhead ERA Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: December 10, 2024 Received: December 10, 2024
Dear Roshana Ahmed:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and
Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Bowhead ERA Wheelchairs
Indications for Use (Describe)
The Bowhead ERA Wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
Submitter I.
Bowhead Design Corp. 6919 32 Ave NW Calgary, AB T3B 0K6 Canada
Contact Person: Tatiana Place Contact Phone: 825-437-2141 Date Prepared: January 10, 2025
II. Device
| Device Proprietary Name: | Bowhead ERA Wheelchairs |
|---|---|
| Common or Usual Name: | Mechanical Wheelchair |
| Classification Name: | Wheelchair, Mechanical |
| Regulation Number: | 890.3850 |
| Product Code: | IOR |
| Device Classification | 1 |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
| Product Name | 510(k) | Applicant |
|---|---|---|
| APEX Manual Wheelchair | ||
| (primary predicate) | K161425 | Motion Composites |
| Panthera X | K220698 | Panthera |
IV. Device Description
The Bowhead ERA Wheelchairs are composite based mechanical, manually operated, wheelchairs intended to be used as a means of mobility for adults restricted to a sitting position. Using the push ring on the rear wheels, users can self-propel themselves forward or backwards. The chairs are designed for riding over various indoor and outdoor surfaces.
5
The Bowhead ERA Wheelchairs include four (4) mechanical wheelchair models with each model containing slightly different design features. Each wheelchair is provided assembled with a sling backrest, seat, seat post, brakes, frame, rear wheels, and casters. The overall length, width and height, backrest angle, COG, wheelbase, and seat width and height are adjustable ensuring comfort for the patient.
V. Indications for Use
The Bowhead ERA Wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position.
VI. Comparison of Technological Characteristics
The subject device has the same intended use as the predicate devices. All of the devices are intended to be used as a means of mobility for persons (adults) restricted to a sitting position.
A comparison of the subject and predicate devices indications for use statements and technological characteristics is provided in the table below.
6
| | Bowhead ERA Wheelchairs | Primary Predicate: APEX Manual
Wheelchair
(K161425) | Panthera X
(K220698) | Analysis |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Bowhead Design Corp. | Motion Composites | Panthera | - |
| Indications for Use | The Bowhead ERA wheelchairs are
manually operated wheelchairs
intended to be used as a means of
mobility for individuals restricted to a
sitting position. | The indications for use of the APEX
Manual wheelchair are to provide
mobility to persons limited to a sitting
position. | Panthera mechanical wheelchairs are
manually operated multifunctional
wheelchairs designed for indoor /
outdoor use and intended to provide
mobility to persons that have the
capability of operating a mechanical
wheelchair. | Different |
| Intended User | Adults | Adults | Adults | Identical |
| Rx/OTC | OTC | OTC | Rx | Identical to K161425 |
| Operation Environment | Indoor/Outdoor | Indoor/Outdoor | Indoor/Outdoor | Identical |
| Control Mode | Self/user propelled, manual mechanical
wheelchair | Self/user propelled, manual mechanical
wheelchair | Self/user propelled, manual mechanical
wheelchair | Identical |
| Folding Method | Rigid | Rigid | Rigid | Identical |
| Weight of Devices | 2.5 – 6 kg w/out wheels & dependent
on configuration with or without
removeable seat. | 9.2 – 10.7 lbs w/o wheels | 4.4 - 4.6 kg | Different |
| Weight Capacity | 110 kg (~242.5 lbs) | 250 lbs | 100 kg | Different |
| Seat Width | Adjustable:
Small: 12" - 15"
Medium: 14.5" - 17"
Large: 17'' - 19.5'' | 12'' — 20'' | 33 - 45 cm
(12.99" - 17.7") | Different |
| Seat Height | Adjustable:
16" - 21" | 14'' – 20'' | Rear: 43 cm
Front: 47 cm | Different |
| Seat Depth | 14"
16" | 12'' – 20'' | 35 — 46 cm | Different |
| | Bowhead ERA Wheelchairs | Primary Predicate: APEX Manual
Wheelchair
(K161425) | Panthera X
(K220698) | Analysis |
| | 18" | | (13.78" – 18.11") | |
| Back Rest Type | Angle Adjustable Sling with or without
Push Handle
Folding Lock-Down Angle Adjustable
with or without Push Handle | Folding Lock-Down Angle Adjustable
straight with or with-out push handle
Ultralight Folding without push Handle | Angle Adjustable, Folding | Different |
| Back Height | 8-25in (dependent backrest selected) | 9" – 21" | 22" – 35" | Different |
| Push Handle | Yes, optional | Yes, optional | Yes, optional | Identical |
| Wheels (Size) | 540, 559, 584 (24", 25", 27.5") | 20" – 26" | 24" | Different |
| Castors | 3", 4", 5", 6" | 3", 4", 5", 6" | 87 mm | Identical to K161425 |
| Arm Rest | Arm rest with integrated Padding,
removeable, height adjustable. | T-Shaped armrest, removable, height
adjustable (by user, no tool required)
Tubular Swing-away | N/A No arm rests | Different |
| Foot rest | Integrated to frame | Integrated to frame | Height Adjustable, integrated to frame. | Identical to K161425 |
| Frame material | Carbon fiber | Aluminum or Carbon Fiber | Carbon Fiber
Reinforced Plastics | Different |
| Safety feature (manual
wheel lock) | Yes, push to lock style. | Yes, push to lock style. | Yes, locks both wheels at once, push to
lock style. | Identical to K161425 |
| Brakes | One hand operation | One hand operation, Scissor lock option | High brakes or one-hand brake | Different |
| Anti-Tip | Yes - optional | Yes | No | Identical to K161425 |
7
8
There are slight differences between the subject and predicate devices with respect to device weight, weight capacity, wheelchair dimensions and ranges of adjustability, and materials of construction; however, these differences do not raise different questions of safety and effectiveness. The results of non-clinical testing demonstrate that the subject device is as safe and effective as the predicate devices:
Performance Data VII.
The following non-clinical tests were performed to support substantial equivalence:
- . RESNA WC-1:2019, Section 1: Determination of static stability
- RESNA WC-1:2019, Section 3: Determination of effectiveness of brakes .
- . RESNA WC-1:2019, Section 5: Determination of overall dimensions, mass and maneuvering space
- RESNA WC-1:2019, Section 7: Measurement of seating and wheel dimensions
- . RESNA WC-1:2019, Section 8: Requirements and test methods for static, impact and fatigue strengths
- RESNA WC-1:2019, Section 13: Determination of coefficient of friction of test surfaces ●
- . Flammability testing
VIII. Conclusion
The Bowhead ERA Wheelchairs have the same intended use and principle of operation as the predicate devices. Non-clinical testing demonstrates that slight differences in design do not alter the safety, efficacy, or performance of the subject device when compared to the predicate devices.
The technological differences between the subject and predicate devices do not raise different questions of safety and effectiveness when compared to the predicate devices. The data presented within this submission support substantial equivalence of the Bowhead ERA Wheelchairs to the identified predicate devices.