# K090052: Cranial Electrical Nerve Stimulator, Model FM 10/C

- Pathway: 510(k) (Traditional)
- Applicant: Johari Digital Healthcare, Ltd.
- Decided: May 29, 2009 after 142 days
- Product code: QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety)
- Device class: 2
- Regulation: 21 CFR 882.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Ces Ultra: named in the summary without a submission number
- (no number) Electronic Pain Relievers: named in the summary without a submission number

## Indications for use
FM 10/C is indicated to be used for: * CES for the treatment of insomnia, depression, or anxiety. * TNS for Symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-traumatic and post-surgical acute pain.

Source page: https://510kreport.com/device/K090052
Methodology: https://510kreport.com/methodology