# K192733: RelieforMe TENS/EMS Device Model UPK-GE01

- Pathway: 510(k) (Traditional)
- Applicant: Umeheal, Ltd.
- Decided: Dec 23, 2019 after 87 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 K912178 (1991). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13, Jkh Health Co., Ltd. (2017) Summary page 4.
- K151035: PulseRelief, Philips Consumer Lifestyle (2015) Summary page 5.

## Cited in the summary but kept off the family tree
- K172933: Mini TENS DEVICE (Model KRES102), TENS & EMS DEVICE (Model KRES100B). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Most influential descendants
- K220738: Motive Knee Wrap (2022), 0 descendants of its own

## Indications for use
TENS: 1. It is intended for temporary relief of pain associated with sore and aching muscles in the shoulder, neck, back, waist, abdomen, lower extremities (legs), upper extremities (arms) due to strain from exercise or normal household and work activities. 2. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS: 3. To stimulate healthy muscles to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the intended areas on the body. 4. To be used for relaxation of muscle spasm, increase of blood flow circulation, prevention or retardation of disuse atrophy, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K192733
Methodology: https://510kreport.com/methodology