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Foot Wrap For Treating Restless Leg Syndrome Symptoms
- Page Type
- Product Code
- Definition
- Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.
- Physical State
- Compressive wrap.
- Technical Method
- Applies pressure to the abductor hallucis and abductor hallucis brevis adequate to affect the peripheral nervous system.
- Target Area
- Abductor hallucis and abductor hallucis brevis muscles.
- Regulation Medical Specialty
- Physical Medicine
- Review Panel
- Neurology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 890.5760
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
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CFR § 890.5760 Nonpowered lower extremity pressure wrap
§ 890.5760 Nonpowered lower extremity pressure wrap.
(a) Identification. A nonpowered lower extremity pressure wrap is a prescription device that applies mechanical pressure by wrapping around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[79 FR 37950, July 3, 2014]