# K964799: Artrotherm Cryotherapy and Thernotherapy

- Pathway: 510(k) (Traditional)
- Applicant: Ormed GmbH
- Decided: Aug 29, 1997 after 273 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
117 later devices descend from it; 2 cite it directly.
0 of 118 devices 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) TTU-100 by Danninger Medical Technology, Inc.: named in the summary without a submission number
- (no number) Hot/Ice® HE500/A by ThermoTemp, Inc.: named in the summary without a submission number

## Most influential descendants
- K023231: Elfcare Device, Models 314A Through 314G (2003), 63 descendants of its own
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps (2006), 52 descendants of its own
- 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

## Indications for use
1. Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

Source page: https://510kreport.com/device/K964799
Methodology: https://510kreport.com/methodology