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510(k) Data Aggregation
K Number
K233067Device Name
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
Manufacturer
Chongqing Rob Linka Science And Technology Co., Ltd.
Date Cleared
2024-07-19
(297 days)
Product Code
NUH, GZJ, IPF, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Rob Linka Science And Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Over-The-Counter Use:
TENS:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, arm,and leg, due to strain from exercise or normal household and work activities.
EMS/NMES:
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Prescription Use:
TENS:
1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
EMS/NMES:
1)Relaxation of muscle spasm;
2)Increase of local blood flow circulation;
3)Prevention or retardation of disuse atrophy;
4)Muscle re-education:
5)Maintaining or increasing range of motion;
6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Device Description
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K Number
K233070Device Name
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
Manufacturer
Chongqing Rob Linka Science And Technology Co., Ltd.
Date Cleared
2024-03-13
(169 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Rob Linka Science And Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SM9027 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
The SM9037 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
The SM9566 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
The SM9065N Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
Device Description
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K Number
K233092Device Name
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
Manufacturer
Chongqing Rob Linka Science and Technology Co., Ltd.
Date Cleared
2024-02-12
(139 days)
Product Code
NUH, GZJ, IPF, NGX, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Rob Linka Science and Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-The-Counter Use:
TENS:
SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leq, due to strain from exercise or normal household and work activities.
SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS/NMES:
SM9075 (mode 25-48, 49-60), SM9910 (mode 9-16, 17-24), SM9067 (mode 10-18, 19-36), SM9587W (mode 9-18, 19-24) are used to stimulate healthy muscles in order to improve and facilitate muscle performance.
To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
SM9075 (mode 25-48), SM9910 (mode 9-16), SM9067 (mode 10-18), SM9587W (mode 9-18) are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
For Prescription Use:
TENS:
SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
PMS/NMES:
SM9075 (mode 25-48, 49-60), SM9910 (mode 9-16, 17-24), SM9067 (mode 10-18, 19-36), SM9587W (mode 9-18, 19-24) are intended for the following use:
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
Device Description
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K Number
K230829Device Name
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Manufacturer
Chongqing Rob Linka Science And Technology Co., Ltd.
Date Cleared
2023-04-26
(30 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Rob Linka Science And Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Device Description
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