The Neurotech Recovery is intended for home use. Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.

The Neurotech Recovery - Back Conductive Garment for the back and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the low back.

The Neurotech Recovery - Back Conductive Garment for the abdomen and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the abdominal area.

Device Description

The Neurotech Recovery is a non-sterile, reusable conductive garment for single patient use only. It acts as an interface between the adhesive electrodes on the patient's skin and the Neurotech Plus electrical stimulator which provides Neuromuscular Electrical Stimulation (NMES) or Transcutaneous Electrical Nerve Stimulation (TENS).

The Neurotech Recovery is available as two options, each targeting separate areas of the human anatomy;

1. The Neurotech Recovery for the lower back which is constructed of the following materials: Main Panels: 89% Nylon & 11% Spandex laminated to Polyurethane, Silver Trace, Binding: 100% Cotton & Hook and Loop Fastener: 100% Nylon
1. The Neurotech Recovery for the abdomen which is constructed of the following materials; Main Panels: 100% Nylon, Binding: 82% Nylon & 18% Elastane, Hook and Loop Fastener: 100% Nylon & Foam Padding: 100% Polyurethane

Included with each Neurotech Recovery conductive garment are conductive gel pads, an extender strap and instructions for use. The device is intended be available by prescription only.

AI/ML Overview

I am sorry; your request cannot be fulfilled. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Neurotech Recovery conductive garment) and primarily focuses on its description, intended use, technological characteristics (stating no new characteristics affect safety/effectiveness), and substantial equivalence to predicate devices. It explicitly states: "No clinical tests have been submitted as part of this premarket notification."

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten text "K 112 934" enclosed in a circle. The text appears to be a combination of letters and numbers. The handwriting is simple and clear, making the text easily readable. The circle around the text emphasizes the content.

Image /page/0/Picture/2 description: The image shows the logo for bio-medical research ltd. The logo consists of the letters "bmr" in a bold, sans-serif font, with the words "bio-medical research ltd." written in a smaller font below. There is a curved line going through the letters "bmr".

Bio-Medical Research Ltd.

Parkmore Business Park West. Galway, Ireland Tel: +353 (0)91 774300 _- Fax: +353 (0)91 774301

This 510k Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Contact Details

Name:	Anne-Marie Keenan
Address:	Bio-Medical Research Ltd.,
	Parkmore Business Park, West
	Galway, Ireland
Telephone:	+353 91 774300
Fax:	+353 91 774302
E-Mail:	akeenan@bmr.ie
Prepared:	December 22, 2011

2. Device Name

Trade Name of Device:	Neurotech Recovery
Common Name:	Conductive Garment
Regulation Number:	21 CFR 882.1320
Regulation Name:	Cutaneous Electrode
Product Code:	GXY
Device Class:	2

3. Identification of Equivalent Legally Marketed Device

510(k) Number:	K070142
Manufacturer:	Bio-Medical Research Ltd.
Trade Name:	System-Abs
510(k) Number:	K082190
Manufacturer:	Bio-Medical Research Ltd.

Baxolve XP Conductive Garment Trade Name:

Directors: T. Kirwan (Chairman), Dr. P.A. Smith (Managing), Dr. B. McDonnell, C. Minogue, P. McGrath

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K11293Y

4. Description of Device

The Neurotech Recovery is available as two options, each targeting separate areas of the human anatomy;

1. The Neurotech Recovery for the lower back which is constructed of the following materials: Main Panels: 89% Nylon & 11% Spandex laminated to Polyurethane, Silver Trace, Binding: 100% Cotton & Hook and Loop Fastener: 100% Nylon
1. The Neurotech Recovery for the abdomen which is constructed of the following materials; Main Panels: 100% Nylon, Binding: 82% Nylon & 18% Elastane, Hook and Loop Fastener: 100% Nylon & Foam Padding: 100% Polyurethane

Included with each Neurotech Recovery conductive garment are conductive gel pads, an extender strap and instructions for use. The device is intended be available by prescription only.

5. Statement of Intended Use/Indications for Use

Intended Use:

The Neurotech Recovery is intended for home use. Sale of the device has been restricted to sale under a prescription order from a licensed practitioner.

Indications for Use:

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Image /page/2/Picture/0 description: The image shows a handwritten text "K 112 93 4" enclosed in an oval shape. The text appears to be a combination of an alphabet and numbers. The handwriting is simple and clear, with each character distinctly visible within the oval.

6. Summary of Technological Characteristics

There are no new technological characteristics that could affect safety or effectiveness of the Neurotech Recovery device. No clinical tests have been submitted as part of this premarket notification. The Neurotech Plus device complies with the following international standards:

I.S. EN ISO 14971 2007 Medical devices Application of risk management to . medical devices
EN ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process (ISO 10993-1:2009)
EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in . vitro cytotoxicity (ISO 10993-5:2009)
. EN ISO 10993-10:2002 & Amendment 1 2006 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2002/Amd. 1:2006

Based on substantial equivalence analysis carried out between the proposed Neurotech Recovery device and the listed predicates, we believe that the proposed device is safe and effective.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Bio-Medical Research Ltd. c/o Ms. Anne-Marie Keenan Quality & Regulatory Engineer Parkmore Business Park West Galway. Ireland

JAN 2 0 2012

Re: K112934 -

Trade/Device Name: Neurotech Recovery Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 21, 2011 Received: December 22, 2011

Dear Ms. Keenan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave as nowe 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 for associated in the 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 r lease be actived that i Dr unation that your device complies with other requirements of the Act that I DA has intates and regulations administered by other Federal agencies. You must or any I caolar statures and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI it rail 607), lacemig (21 CFR 803); good manufacturing practice requirements as set de rice-related duverse ovents) (21 CFR Part 820); and if applicable, the electronic a form in the quality by bioline (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Anne-Marie Keenan

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/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 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.htm.

Sincerely yours,

Debra Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

K112934

Neurotech Recovery-Back

Indications for Use:

Prescription Use _X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K112934

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).