PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE

K971708 · J & J Engineering, Inc. · HCC · Feb 18, 1998 · Neurology

Device Facts

• Record ID: K971708
• Device Name: PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
• Applicant: J & J Engineering, Inc.
• Product Code: HCC · Neurology
• Decision Date: Feb 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to be used for physiological monitoring, biofeedback training, incontinence, relaxation training, muscle reeducation and research.

Device Story

J&L I-410 Physiological Monitoring & Biofeedback Instrument; used for monitoring physiological signals, biofeedback, incontinence management, relaxation training, and muscle reeducation. Device captures physiological data; processes signals to provide feedback to user/clinician. Used in clinical or research settings; operated by healthcare professionals or trained users. Output facilitates patient awareness of physiological states; aids in muscle control and relaxation therapy. Benefits include improved patient outcomes in incontinence and muscle rehabilitation.

Clinical Evidence

No clinical data provided; 510(k) clearance based on substantial equivalence determination.

Technological Characteristics

Physiological monitoring and biofeedback instrument. Class II device. Technical specifications, materials, and specific sensing modalities not detailed in provided documentation.

Indications for Use

Indicated for patients requiring physiological monitoring, biofeedback training, incontinence treatment, relaxation training, muscle reeducation, or research applications. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Submission Summary (Full Text)

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- ED

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Anand Akerkar, Ph.D. Official Correspondent for J&J Engineering, Inc. c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

Re: K971708 Physiological Monitoring and Trade Name: Biofeedback Training Device Requlatory Class: II нсс Product Code: November 20, 1997 Dated: November 20, 1997 Received:

Dear Dr. Akerkar:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with would the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does_ not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Anand Akerkar, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K_971708

Device Name:__J&L I-410_Physiological Monitoring & Biofeedback Instrument

Indications For Use:

This device is intended to be used for physiological monitoring, biofeedback training, incontinence, relaxation training, muscle reeducation and research.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | | |
| | (Division Sign-Off) | |
| | Division of General Restorative Devices | |
| 510(k) Number | K971708 | |

Prescription Use_L (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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