Ebice
FDA 510(k) K953532 · Electro-Biology, Inc.
510(k) numberK953532
Submission
- Device name
- Ebice
- Applicant
- Electro-Biology, Inc.
Parsippany, NJ, US - Received
- July 27, 1995
- Decision date
- October 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K992333 | Ebi Omega 21 SystemMNI · Traditional | 10/08/1999SE |
| K992367 | Ebi Xfix Dynafix System Ha Coated ScrewsHWC · Traditional | 09/23/1999SE |
| K991941 | Ebi Xfix DFS Rail SystemKTT · Traditional | 08/19/1999SE |
| K991092 | Ebi Spinelink Anterior Cervical Spinal SystemKWQ · Special | 04/29/1999SE |
| K990303 | Ebi Omega 21 SystemKWP · Traditional | 04/29/1999SE |
| K990459 | Ebi Vuecath Endoscopic SystenHRX · Traditional | 04/23/1999SE |
| K990999 | Modification of: Ebi Spinelink SystemMAI · Special | 04/14/1999SE |
| K984027 | Ebi Spinelink SystemMNI · Traditional | 01/19/1999SE |
| K982484 | Ebi Vuecath Endoscopic Spinal SystemHRX · Traditional | 10/08/1998SE |
| K982908 | Modification to Ebi Spinelink SystemKWP · Special | 08/28/1998SE |
Questions and answers
When was Ebice cleared by the FDA?
Ebice (K953532) received a 510(k) decision of Substantially Equivalent on October 4, 1995, 69 days after the submission was received.
What is the product code of K953532?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.