# K073008: KFH Energy, Model: E1

- Pathway: 510(k) (Traditional)
- Applicant: Kingfisher Healthcare NV
- Decided: Mar 11, 2008 after 139 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: 2 generations back to K002874 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896948: Alpha-Stim CS, Electromedical Products, Inc. (1990) Summary page 2.
- K881753: Alpha-Stim 350, Electromedical Products, Inc. (1988) Summary page 2.
- K831145: Alpha-Stim 350, Electromedical Products, Inc. (1983) Summary page 2.
- K831144: Alpha-Stim 2000, Electromedical Products, Inc. (1983) Summary page 2.
- K915210: Electro-Nerve Stimulator Tens Model Micro Plus-a, Biomedical Life Systems, Inc. (1992) Summary page 2.
- K050435: E-Stim II, Lhasa Oms, Inc. (2005) Summary page 2.
- K994265: Medisana Digital Tens, Fuji Dynamics Limited (2000) Summary page 2.
- K903394: Globalcare Micro 11 and Microcare (Tens), Globalcare Intl., Inc. (1991) Summary page 2.
- K923298: Micro 100,200,300, & 400 Tens, Skylark Device Co., Ltd. (1992) Summary page 3.

## Indications for use
The KFH Energy device is indicated for the symptomatic relief of: Chronic Intractable Pain Post-Traumatic Pain Post-Surgical Pain

Source page: https://510kreport.com/device/K073008
Methodology: https://510kreport.com/methodology