# K050687: Axiom EPS8000

- Pathway: 510(k) (Traditional)
- Applicant: Axiom Worldwide, Inc.
- Decided: Jul 28, 2005 after 133 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
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. The FDA summary names no predicate by number.

## Indications for use
Stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation. PAIN MANAGEMENT * For adjunctive treatment of post-traumatic pain syndromes * For management and symptomatic relief of chronic (long-term) intractable pain and inflammation * As an adjunctive treatment the management of post-surgical pain problems MUSCLE STIMULATION * Relaxation of Muscle Spasms * Prevention or Retardation of Tissue Atrophy * Increasing Local Blood Circulation * Muscle Re-education * Immediate Post-Surgical Stimulation of Calf Muscles to prevent venous thrombosis * Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K050687
Methodology: https://510kreport.com/methodology