# K062641: Body-Stim, Biomodulator, Best-Rsi, Best Pro, Model Best-AV1

- Pathway: 510(k) (Traditional)
- Applicant: Avazzia, Inc.
- Decided: Apr 30, 2007 after 236 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951951 (1996). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042912: INTERX5000, Neuro Resource Group, Inc. (2005) Summary page 1.

## Most influential descendants
- K123099: Best-AV2 Pro-Sport (tm) (2014), 0 descendants of its own
- K071878: Delta Scanner, Delta Scanner Pro, DS Spine Pro, DS Sports Pro and DS Rehab (2007), 0 descendants of its own

## Recalls of this device
- Jun 29, 2007 · Not classified · Z-1207-2007: Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
- Jun 29, 2007 · Not classified · Z-1208-2007: Plastic Cases may crack due to manufacturing by the supplier not meeting specifications
- Jun 29, 2007 · Not classified · Z-1210-2007: Plastic Cases may crack due to manufacturing by the supplier not meeting specifications

## Indications for use
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K062641
Methodology: https://510kreport.com/methodology