# K200694: Perfect EMS

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: Jun 4, 2021 after 444 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: 8 generations back to K940301 (1994). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190347: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2019) Summary page 5.

## Most influential descendants
- K230926: Ova+ (K-OVAP-USA) (2023), 0 descendants of its own

## Indications for use
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. EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K200694
Methodology: https://510kreport.com/methodology