# K112392: Hivox Biotek Inc.

- Pathway: 510(k) (Traditional)
- Applicant: Hivox Biotek, Inc.
- Decided: Mar 19, 2012 after 214 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- 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 K940301 (1994). 6 ancestors in all.
58 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060846: Therapeutic Massage Companion, Endurance Therapeutics (2007) Summary page 1.
- K040512: Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401, Well-Life Healthcare, Inc. (2004) Summary page 1.

## Most influential descendants
- K122744: Prospera Otc Tens Electronic Pulse Massager (2013), 55 descendants of its own
- K133929: Health Expert Elctronic Stimulator (2014), 26 descendants of its own
- K143207: Revitive IX (OTC) (2015), 17 descendants of its own
- K151834: BEMER Classic Set, BEMER Pro-Set (2017), 11 descendants of its own
- K190783: Health Expert Electronic Stimulator (model: AST-300L) (2020), 6 descendants of its own

## Indications for use
The Pennypad 904 and Pennypad 909 are indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K112392
Methodology: https://510kreport.com/methodology