# K083250: Neuromed Electroanalgesic Delivery Systems

- Pathway: 510(k) (Traditional)
- Applicant: Aa Neuromed Corp.
- Decided: Aug 18, 2009 after 287 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- 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 K932897 (1994). 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)
- K932897: Transcutaneous Electrical Nerve Stimulator, Nemectron GmbH (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K030048: HA Pmi Femoral Hip Stem, Biomet Orthopedics, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Pain Management for use with interferential and/or TENS mode programs/parameters Stimulate peripheral nerves for the purpose of providing pain relief. Management and symptomatic relief of chronic (long-term) intractable pain. Adjunctive treatment of post-traumatic pain. Adjunctive treatment in the management of post-surgical pain. Muscle Stimulation for use with muscle stimulation programs Increasing local blood circulation. Maintaining or increasing range of motion. Muscle Re-education. Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K083250
Methodology: https://510kreport.com/methodology