Tecnol Patient Use Ice Pack
FDA 510(k) K760782 · Tecnol New Jersey Wound Care, Inc.
510(k) numberK760782
Submission
- Device name
- Tecnol Patient Use Ice Pack
- Applicant
- Tecnol New Jersey Wound Care, Inc.
Hammonton, NJ, US - Received
- October 5, 1976
- Decision date
- December 2, 1976
- Decision
- Substantially Equivalent (SESE)
- 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
Other 510(k)s with product code ILO
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|---|---|---|---|
| K213097 | Armory MotionILO · Traditional | Pain Management Technologies, Inc. | 06/10/2022SE |
| K083008 | CoolskinILO · Abbreviated | Elbio Co., Ltd. | 06/10/2009SE |
| 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 |
More from Ormed GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K913043 | Modification Tecnol Fluidshield Surgical MasksFXX · Traditional | 08/23/1991SE |
| K911891 | Fluidshield(Tm) Cone Classic(Tm) II Surgical MaskFXX · Traditional | 07/12/1991SE |
| K911907 | Fluidshield Cone Classic II Surg Mask W/Splash VisFXX · Traditional | 07/08/1991SE |
| K896193 | Tecnol Lazer(Tm) Surgical MaskFXX · Traditional | 02/27/1990SE |
| K894205 | Tecnol Silk StripFPX · Traditional | 07/25/1989SE |
| K893702 | Tecnol Gaiters Product Number 47725-010FXP · Traditional | 06/23/1989SE |
| K891187 | Tecnol Naso-Gastric Tube HolderBSS · Traditional | 05/30/1989SE |
| K891178 | Tecnol Secure-All Tube HolderEYZ · Traditional | 05/23/1989SE |
| K884440 | Tecnol Variable Tension BandageNAD · Traditional | 01/17/1989SN |
| K882640 | Tecnol Secure-All Pelvic Traction BeltKQZ · Traditional | 07/27/1988SE |
Questions and answers
When was Tecnol Patient Use Ice Pack cleared by the FDA?
Tecnol Patient Use Ice Pack (K760782) received a 510(k) decision of Substantially Equivalent on December 2, 1976, 58 days after the submission was received.
What is the product code of K760782?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.