FDA 510(k) Applications for Medical Device Product Code "ISA"
(Massager, Therapeutic, Electric)
| 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 |
| K240358 | Shenzhen Dongdixin Technology Co., Ltd. | ShockPhysio Mobile (model SW3200 Basic) | 06/05/2024 |
| K173692 | Storz Medical AG | D-Actor 200 Vibration Massage System | 04/13/2018 |
| K243488 | TermoSalud | VMAT PRO | 02/06/2025 |
| 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 |
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