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510(k) Data Aggregation
K Number
K210825Device Name
Revitive Medic Coach (Model Number 5575AQ)
Manufacturer
Actegy, Ltd.
Date Cleared
2021-12-17
(273 days)
Product Code
NGX, GZJ, IPF, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Actegy, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
(1) When using Electrical Muscle Stimulation (NMES), Revitive is intended:
· for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
- · to temporarily increase local blood circulation in healthy leg muscles
- · to stimulate healthy muscles in order to improve and facilitate muscle performance
- · to temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities legs) due to strain from exercise or normal household duties
- · for relaxation of muscle spasm,
- · for increase of blood flow circulation.
- · for prevention or retardation of disuse atrophy,
- · for muscle re-education,
- · for maintaining or increasing range of motion, and
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Provide quadricep strengthening
- · Improve knee stability secondary to quadricep strengthening
(2) When using Revitive to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:
- · symptomatic relief and management of chronic, intractable pain
- · relief of pain associated with arthritis
· temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities.
Device Description
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K Number
K192887Device Name
Revitive Medic Plus, Revitive Advanced 2
Manufacturer
Actegy, Ltd.
Date Cleared
2020-05-04
(207 days)
Product Code
NGX, GZJ, IPF, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Actegy, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NMES:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
- For relaxation of muscle spasm.
- Increase of blood flow circulation,
- Prevention or retardation of disuse atrophy,
- Muscle re-education.
- Maintaining or increasing range of motion,
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- For users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
TENS:
- For symptomatic relief and management of chronic intractable pain
- Relief of pain associated with arthritis
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities
Device Description
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K Number
K190924Device Name
Revitive Medic Plus, Revitive Advanced 2
Manufacturer
Actegy, Ltd.
Date Cleared
2019-07-05
(87 days)
Product Code
NGX, IPF, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Actegy, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NMES:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities
- (arms) and lower extremities (legs) due to strain from exercise or normal household duties
- For relaxation of muscle spasm,
- Increase of blood flow circulation,
- Prevention or retardation of disuse atrophy,
- Muscle re-education,
- Maintaining or increasing range of motion, and
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
TENS:
- For symptomatic relief and management of chronic intractable pain
- Relief of pain associated with arthritis
- For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities
Device Description
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K Number
K152480Device Name
Revitive Medic; Revitive MV; Revitive LV
Manufacturer
Actegy, Ltd.
Date Cleared
2016-03-31
(213 days)
Product Code
NGX, NUH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Actegy, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
· To temporarily increase local blood circulation in healthy leg muscles
· To stimulate healthy muscles in order to improve and facilitate muscle performance.
· For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.
Device Description
Not Found
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