Model 1100 Cold Therapy Device
FDA 510(k) K955057 · Smith and Nephew Donjoy, Inc.
510(k) numberK955057
Submission
- Device name
- Model 1100 Cold Therapy Device
- Applicant
- Smith and Nephew Donjoy, Inc.
Carsbad, CA, US - Received
- November 6, 1995
- Decision date
- March 8, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5720
- Specialty
- Physical Medicine
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| K073675 | T-Pump Localized Temperature Therapy PumpILO · Traditional | Gaymar Industries, Inc. | 05/08/2008SE |
| K072152 | Juniper CLN1 Dermal Cooling DeviceILO · Traditional | Juniper Medical, Inc. | 09/07/2007SE |
| K070402 | Modification to Polar Care 500ILO · Special | Breg, Inc. | 03/29/2007SE |
| K040317 | Ivc SystemILO · Traditional | Mark H. Friedman | 05/07/2004SE |
| K973023 | Incare Hot/Ice System Foot/Ankle BlanketILO · Traditional | Hollister, Inc. | 11/03/1997SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | Adroit Medical Systems, Inc. | 09/10/1997SE |
| K964799 | Artrotherm Cryotherapy and ThernotherapyILO · Traditional | Ormed GmbH | 08/29/1997SE |
| K964354 | Artocool-S Water Circulating Cold PackILO · Traditional | Ormed GmbH | 08/29/1997SE |
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| K963490 | Protective Restraint - BeltsFMQ · Traditional | 11/12/1996SE |
| K963489 | Wheel Chair AccessoryFMQ · Traditional | 11/12/1996SE |
| K962462 | Musclemax Plus Electrical Muscle StimulatorIPF · Traditional | 09/23/1996SE |
| K951350 | Musclesense Electromyography DeviceHCC · Traditional | 06/23/1995SE |
| K945687 | Rounded Cannulated Inside-Out (Rci) Acl ScrewHWC · Traditional | 06/22/1995SN |
| K946313 | Tibial Routers, Femoral Routers and Tube Graft SizerHRX · Traditional | 03/17/1995SE |
| K945236 | Aims Cannulated Acl Screw (7MM Diameter)HWC · Traditional | 02/03/1995SE |
| K932592 | Brace NeutralizerGZJ · Traditional | 03/18/1994SE |
Questions and answers
When was Model 1100 Cold Therapy Device cleared by the FDA?
Model 1100 Cold Therapy Device (K955057) received a 510(k) decision of Substantially Equivalent for Some Indications on March 8, 1996, 123 days after the submission was received.
What is the product code of K955057?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.