FDA 510(k) Applications for Medical Device Product Code "ISA"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K221865 | BTL Industries Inc. | BTL-094 | 04/14/2023 |
K030876 | CYNOSURE, INC. | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | 01/22/2004 |
K220538 | EMS Electro Medical Systems SA | DolorClast Radial | 07/11/2022 |
K002908 | JET THERAPY | JET THERAPY | 08/30/2001 |
K053225 | LPG ONE, INC | CELLU M6 KEYMODULE I | 11/06/2006 |
K990445 | LPG USA, INC. | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | 01/18/2000 |
K210166 | Medispec Ltd. | Omnispec ED1000 | 01/27/2023 |
K173692 | Storz Medical AG | D-Actor 200 Vibration Massage System | 04/13/2018 |
K182682 | Tissue Regeneration Technologies | OrthoGold 100 | 12/21/2018 |
K210451 | Tissue Regeneration Technologies, LLC | OrthoGold 100 | 05/05/2021 |
K213120 | Tissue Regeneration Technologies, LLC DBA as SoftWave TRT | OW100S (model OW100S-US) | 10/12/2022 |