# K913522: Solitens Modified

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Designer Products, Inc.
- Decided: Aug 28, 1991 after 33 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982961: Medipoint (1999), 3 descendants of its own
- 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
- K041359: Body Clock Stimplus and Stimplus Pro (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K913522
Methodology: https://510kreport.com/methodology