ReGrasp

K153163 · Rehabtronics, Inc. · GZI · Apr 7, 2016 · Neurology

Device Facts

• Record ID: K153163
• Device Name: ReGrasp
• Applicant: Rehabtronics, Inc.
• Product Code: GZI · Neurology
• Decision Date: Apr 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

ReGrasp is an external functional neuromuscular stimulator; delivers electrical stimulation to muscles to facilitate hand function and range of motion. Device operates via FES and NMES modalities; targets patients with hemiplegia or upper limb paralysis from stroke, brain injury, or C5 spinal cord injury. Used in clinical or home settings under prescription; provides therapeutic benefits including muscle re-education, atrophy reduction, and improved circulation. System applies electrical pulses to stimulate muscle contraction; assists users in regaining functional hand movements.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

External functional neuromuscular stimulator; Class II device; Product codes GZI, IPF. Operates as an electrical stimulation device for FES and NMES applications. Regulated under 21 CFR 882.5810.

Indications for Use

Indicated for patients with hemiplegia or upper limb paralysis due to stroke, traumatic/acquired brain injury, or C5 cervical spinal cord injury to improve hand function and range of motion, and for NMES applications including atrophy prevention, circulation increase, spasm reduction, and muscle re-education.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known)

K153163

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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