3 in 1 TENS UNIT (TC1241, TC2241, TS1241)

• K Number: K251187
• Device Name: 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
• Manufacturer: Changsha Anxiang Medical Technology Co., Ltd
• Date Cleared: 2025-07-28 ( 102 days)
• Product Code: NUH
• Regulation Number: 882.5890
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A

Intended Use

1) TENS
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

2) EMS
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "3 in 1 TENS UNIT" (K251187) does not contain any information about acceptance criteria or the specifics of a study proving the device meets those criteria, particularly not for an AI/ML medical device.

The document is a standard FDA clearance letter for a Class II medical device (Transcutaneous Electrical Nerve Stimulator For Pain Relief). It primarily covers:

• Device Identification: Trade name, regulation number, product code.
• Regulatory Status: Declaration of substantial equivalence to a predicate device.
• General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
• Additional Controls: Notes potential for special controls for Class II devices and references regulations like the Quality System (QS) regulation.
• Compliance: Reminds the applicant of various other FDA regulations (e.g., UDI Rule, MDR).
• Contact Information: Provides resources for further inquiries.
• Indications for Use: Describes the intended use for TENS (pain relief) and EMS (muscle performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The information you're asking for typically comes from the premarket submission itself (which might include detailed validation studies, performance data, and the methodology for establishing acceptance criteria), not from the FDA's clearance letter. This type of detail is particularly crucial for AI/ML-based devices, which this TENS unit is not described as.

If you have a document describing the actual performance study and acceptance criteria for this specific device, please provide it, and I would be happy to help analyze it.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).