# K980448: Model PS-1 Pena Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Apr 3, 1998 after 57 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) P.B. Services Model A-200 Constant Current Peripheral Nerve Stimulator: named in the summary without a submission number
- (no number) Radionics Model 433-A General Hospital Stimulator: named in the summary without a submission number

## Most influential descendants
- K172381: Digitimer DS7AP Constant Current Stimulator (2018), 1 descendant of its own
- K233098: MYOTouch Muscle Stimulator (2024), 0 descendants of its own

## Indications for use
The PS-1 is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.

Source page: https://510kreport.com/device/K980448
Methodology: https://510kreport.com/methodology