# K232786: Stimulation System  (PA series, PR series, S series and Q series)

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: May 16, 2024 after 248 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: 7 generations back to K930530 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080950: Stiwell MED4, Otto Bock, Austria GmbH (2009) Summary page 5.

## Indications for use
PA&PR series: The PA&PR series are a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator, PA&PR series are indicated for the following conditions: • Relaxation of muscle spasms, • Prevention or retardation of disuse atrophy, • Increasing local blood circulation, • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, • Maintaining or increasing range of motion, • Muscle re-education. Environments of Use: Clinics, hospital. Patient population: Adults S&Q series: The S&Q series are a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator, S&Q series are indicated for the following conditions: • Relaxation of muscle spasms, • Prevention or retardation of disuse atrophy, • Increasing local blood circulation, • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, • Maintaining or increasing range of motion, • Muscle re-education. As a transcutaneous electrical nerve stimulator for pain relief, S&Q series are indicated for the following conditions: • Symptomatic relief and management of chronic (long-term), intractable pain, • Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. Environments of Use: Clinics, hospital and home environments. Patient population: Adults

Source page: https://510kreport.com/device/K232786
Methodology: https://510kreport.com/methodology