# K151279: Counter OTC TENS Device, Model CSD-737Z

- Pathway: 510(k) (Traditional)
- Applicant: Counter Scientific Development (Gz), Ltd.
- Decided: Dec 16, 2015 after 216 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 4. To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 1 or Auto 3.. To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes A, B, E or Auto l or Auto 4. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes A and C or Auto 1, Auto 2, Auto 3, or Auto 4. To be used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode A or Mode B.

Source page: https://510kreport.com/device/K151279
Methodology: https://510kreport.com/methodology