# K023231: Elfcare Device, Models 314A Through 314G

- Pathway: 510(k) (Traditional)
- Applicant: Mediseb, Ltd.
- Decided: Apr 4, 2003 after 189 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 K912178 (1991). 10 ancestors in all.
63 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982324: Vectra Pro Models 2 and 4, Chattanooga Group, Inc. (1999) Summary page 2.
- K990787: TRIO 300, Ito Co., Ltd. (1999) Summary page 2.
- K913026: Ttu-100THERMAL Therapy Unit, Danninger Medical Technology, Inc. (1991) Summary page 2.
- K964799: Artrotherm Cryotherapy and Thernotherapy, Ormed GmbH (1997) Summary page 2.
- (no number) Thera-Temp Flexible Cold/Hot Packs: named in the summary without a submission number

## Most influential descendants
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own
- K090094: Zeltiq System (2009), 32 descendants of its own
- K120023: Zeltiq Coolsculpting (2012), 31 descendants of its own

## Indications for use
For Microcurrent and IFC (Premodulated Interferential) electrical stimulation using models 314A, 314B, 314C, 314F and 314G: - Symptomatic relief and management of chronic intractable pain - Adjunctive treatment in the management of post-surgical and post-traumatic pain. For VMS Burst, Russian and Biphasic Symmetrical Pulses electrical stimulation using models 314F and 314G: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Prevention of venous thrombosis of the calf muscles immediately after surgery For HotKold therapy using models: 314A, 314B, 314C, 314D, 314E: - Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. - Temporary relief of minor aches and pains and muscle spasms

Source page: https://510kreport.com/device/K023231
Methodology: https://510kreport.com/methodology