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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

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]

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

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]