(157 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on the electrical stimulation functionality and intended uses.
Yes
The device is indicated for therapeutic uses such as improving hand-function, increasing range of motion, preventing disuse atrophy, and reducing muscle spasms in patients with various neurological conditions.
No
The device is described as an electrical stimulation device for therapeutic purposes (e.g., improvement of hand-function, reduction of muscle spasms), not for diagnosing conditions.
No
The device is described as an "electrical stimulation device," which inherently implies hardware components for delivering electrical stimulation. The summary does not mention it being software-only.
Based on the provided information, the ReGrasp device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed for the ReGrasp are all related to electrical stimulation of muscles and nerves for therapeutic purposes (improving hand function, range of motion, reducing spasms, etc.). This is a form of physical therapy or rehabilitation.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. The ReGrasp does not involve any such testing of biological samples.
The ReGrasp is clearly a therapeutic medical device used for electrical stimulation, not a diagnostic device.
N/A
Intended Use / Indications for Use
The ReGrasp is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES):
- Improvement of hand-function and active range of motion in patients with hemiplegia or upper limb paralysis due to stroke, traumatic or acquired brain injury, or C5 level cervical spinal cord injury.
Neuromuscular Electrical Stimulation (NMES):
- Maintenance and/or increase of range of motion
- Prevention and/or reduction of disuse atrophy
- Increase of local blood circulation
- Reduction of muscle spasms
- Muscle re-education
Product codes
GZI, IPF
Device Description
The ReGrasp is an electrical stimulation device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hand, upper limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the future. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2016
Rehabtronics Inc. Mike Pearson Management Representative #4532, 10230 Jasper Avenue Edmonton, Alberta Canada T5J 4P6
Re: K153163
Trade/Device Name: ReGrasp Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: March 9, 2016 Received: March 11, 2016
Dear Mr. Pearson:
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. 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J. Hoffmann -A
- for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ReGrasp
Indications for Use (Describe)
The ReGrasp is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES):
- Improvement of hand-function and active range of motion in patients with hemiplegia or upper limb paralysis due to stroke, traumatic or acquired brain injury, or C5 level cervical spinal cord injury.
Neuromuscular Electrical Stimulation (NMES):
- Maintenance and/or increase of range of motion
- Prevention and/or reduction of disuse atrophy
- Increase of local blood circulation
- Reduction of muscle spasms
- Muscle re-education
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Type 1 | |
| Type 2 |
X | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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