# K152128: 2-in-1 Abdominal Muscle Training & Back Pain Relief System

- Pathway: 510(k) (Traditional)
- Applicant: Tohkai Precision Electrical Manufactory (Shenzhen) Limited
- Decided: Dec 23, 2015 after 145 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K940301 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102295: X2ABS Dual Channel Fitness Belt, Leto Enterprises Incorporation (2011) Summary page 5.
- K060846: Therapeutic Massage Companion, Endurance Therapeutics (2007) Summary page 5.
- K133929: Health Expert Elctronic Stimulator, Shenzhen Osto Technology Company Limited (2014) Summary page 5.

## Indications for use
The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two modes of stimulation; a transcutaneous electrical nerve stimulation (TENS) BP-313 mode and a powered muscle stimulation (PMS) TS-212 mode. The TENS(BP-313 Mode) is indicated for temporary relief of pain associated with sore and aching muscles in the waist, back, arm, leg due to strain from exercise or normal household and work activities. The PMS (TS-212 Mode) is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen. This system is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K152128
Methodology: https://510kreport.com/methodology