# K073438: Prostim 1000/2000

- Pathway: 510(k) (Traditional)
- Applicant: Bio Protech, Inc.
- Decided: Feb 7, 2008 after 62 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: 3 generations back to K921441 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061476: Electro-Nerve Stimulator Tens, Model BMLS06-1, Biomedical Life Systems, Inc. (2006) Summary page 1.
- K021436: Ttech Model 200E + Tens Device, Theratech, Inc. (2002) Summary page 1.
- K060246: Infrex, Johari Digital Healthcare, Ltd. (2006) Summary page 1.

## Indications for use
The PROSTIM 1000/2000 is used for the symptomatic relief and management of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.

Source page: https://510kreport.com/device/K073438
Methodology: https://510kreport.com/methodology