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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.

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
• 2. 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.

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."

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