# K112148: Powered Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Valmed, SA
- Decided: Apr 30, 2012 after 278 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: 1 generation back to K022175 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022175: P4 Physio, Valmed Corp. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K092448: Hivox Electric Stimulator Tens & Ems, HD2, Hivox Biotek, Inc. (2010). Our reading of the summary gave K092448, FDA’s number for Hivox Electric Stimulator Tens & Ems, HD2 (Hivox Biotek, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Styline 882”. Kept off the family tree. Summary page 1.

## Indications for use
Indications for EMS use are: > Prevention or retardation of muscle disuse atrophy > Relaxation of muscle spasms > Increasing local blood circulation > Muscle re-education > Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis > Maintaining or improving range of motion of extremities Indications for TENS use are: > Symptomatic relief and management of chronic, intractable pain, and > Adjunctive treatment for post-surgical and post-trauma acute pain

Source page: https://510kreport.com/device/K112148
Methodology: https://510kreport.com/methodology