TENS7000 Rechargeable (Model:TENS7000 Rechargeable)

FDA 510(k) K230829 · Chongqing Rob Linka Science and Technology Co., Ltd.

Substantially Equivalent

510(k) numberK230829

Submission

Device name
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Applicant
Chongqing Rob Linka Science and Technology Co., Ltd.
Chongqing, CN
Received
March 27, 2023
Decision date
April 26, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)NUH · Traditional Shenzhen Jiantuo Electronics Co., Ltd.12/31/2025SE
K253740Tens&Ems (HZ9151B, HZ9151C, HZ9151D)NUH · Traditional Hong Qiangxing (Shenzhen) Electronics Limited12/23/2025SE
K251958VEINOPLUS BackNUH · Traditional Dynapulse Medical12/23/2025SE
K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)NUH · Traditional Bozhou Rongjian Medical Appliance Co., Ltd.11/24/2025SE
K251856Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special Everyway Medical Instruments Co.,Ltd11/21/2025SE
K243131Triathlon ProNUH · Traditional Sigma Biomedical11/07/2025SE

More from Sigma Biomedical

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K233067Wireless TENS & EMS (Model SM9110,SM9113,SM9116)NUH · Traditional 07/19/2024SE
K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)NGX · Traditional 03/13/2024SE
K233092Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)NUH · Traditional 02/12/2024SE

Questions and answers

When was TENS7000 Rechargeable (Model:TENS7000 Rechargeable) cleared by the FDA?

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) (K230829) received a 510(k) decision of Substantially Equivalent on April 26, 2023, 30 days after the submission was received.

What is the product code of K230829?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.