# K980958: Hakomed Elecdt/Vacupulls

- Pathway: 510(k) (Traditional)
- Applicant: Alive, Inc.
- Decided: May 11, 1998 after 56 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For adjunctive use in post-traumatic pain syndromes; for management and symptomatic relief of chronic (long-term) pain; as an adjunctive treatment in the management of post-surgical pain problems; relaxation of muscle spasms; prevention or retardation of tissue atrophy; increasing local blood circulation; muscle re-education; immediate postsurgical stimulation of calf muscles to prevent phlebothrombosis; and maintaining or increasing range of motion. To stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.

Source page: https://510kreport.com/device/K980958
Methodology: https://510kreport.com/methodology