510(k) K183450
- Device
- EmBody System
- Applicant
- InMode MD Ltd.
- 510(k) number
- K183450
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-06-20
- Date received
- 2018-12-12
- Regulation
- 890.5660
- Classification name
- Massager, Therapeutic, Electric
- Medical specialty
- Physical Medicine
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amit Goren
- Address
- Tabor Bldg., Shaar Yokneam Yokneam IL 2069200 2069200
FDA Registration Numbers#
- 3030420005
- 3002808227
- 3011070163
- 3016746323
- 3004940677
- 3030230686
- 3016496662
- 3016087653
- 3021177911
- 3015452693
- 3007544634
- 3017954802
- 3010511300
- 3008929787
- 3007712511
- 3013917867
- 3035374386
- 8040537
- 3016446653
- 3043657394
- 3038715747
- 3017263740
- 3010402752
- 3010836847
- 8010720
- 3008729892
- 3011782009
- 3008915316
- 3004784537
- 3022747124
- 3038280308
- 2954354
- 3013652305
- 3009736547
- 3011307265
- 3016512343
- 3006153348
- 3023339107
- 3013602304
- 3006515340
- 3006850277
- 1725006
- 3043140693
- 9612147
- 3015283772
- 3008085016
- 3006807694
- 1222993
- 3013734919
- 3011670002
- 8040510
- 3015779311
- 2087572
- 3005695724
- 3018994966
- 3015433394
- 3016675013
- 3026400760
- 3007421149
- 3001431138
- 3013539104
- 3013517192
- 3016413636
- 9680721
- 3010363436
- 3007491751
Source Documents#
Other 510(k) Records For Product Code ISA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243488 | VMAT PRO | Termosalud | 2025-02-06 |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | 2024-06-05 |
| K221865 | BTL-094 | BTL Industries, Inc. | 2023-04-14 |
| K210166 | Omnispec ED1000 | Medispec, Ltd. | 2023-01-27 |
| K213120 | OW100S (model OW100S-US) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | 2022-10-12 |
| K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | 2022-07-11 |
| K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021-05-05 |
| K182682 | OrthoGold 100 | Tissue Regeneration Technologies | 2018-12-21 |
| K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018-04-13 |
| K053225 | CELLU M6 KEYMODULE I | Lpg One, Inc. | 2006-11-06 |
| K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | Cynosure, Inc. | 2004-01-22 |
| K002908 | JET THERAPY | Jet Therapy | 2001-08-30 |
| K990445 | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | Lpg USA, Inc. | 2000-01-18 |
| K952990 | SPIN ROLLERE | Kinsei Shiatsu, Inc. | 1995-09-29 |
| K952041 | BODYFLEX MASSAGER | Truro'S Ent. | 1995-08-14 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases