# K982961: Medipoint

- Pathway: 510(k) (Traditional)
- Applicant: Medipoint, Ltd.
- Decided: Jun 7, 1999 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 K913522 (1991). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913522: Solitens Modified, Innovative Designer Products, Inc. (1991) Summary page 2.

## Most influential descendants
- K071120: Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999 (2008), 2 descendants of its own
- K142686: StimPad OTC (2014), 0 descendants of its own
- K090866: Neurocalm Model 1 and 2 (2009), 0 descendants of its own

## Indications for use
MEDIPOINT is an electronic pulse generator that has been designed to provide symptomatic relief of chronic intractable pain and post-traumatic acute pain (TENS).

Source page: https://510kreport.com/device/K982961
Methodology: https://510kreport.com/methodology