510(k) K220538
- Device
- DolorClast Radial
- Applicant
- EMS Electro Medical Systems SA
- 510(k) number
- K220538
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-11
- Date received
- 2022-02-25
- Regulation
- 890.5660
- Classification name
- Massager, Therapeutic, Electric
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Timothée Deblock
- Address
- Ch. De La Vuarpilliere 31 Nyon CH 1260 1260
FDA Registration Numbers#
- 3013423303
- 3008048783
- 3027057394
- 3021393315
- 3014345255
- 3009428929
- 3004624259
- 3014948462
- 9611102
- 3016678950
- 3021235806
- 3012341715
- 3011197718
- 3010391227
- 3009072217
- 3004264602
- 3026270764
- 3013787796
- 3037003917
- 3014945403
- 3016660845
- 3016171836
- 3026875458
- 3010310816
- 3039388306
- 3037609256
- 3013875436
- 3015968545
- 3009068676
- 3016053560
- 3008729549
- 3021593882
- 3017961176
- 3029338825
- 3010547367
- 3015287734
- 3044461452
- 3016904853
- 3033435469
- 3008103948
- 3038320370
- 3042070639
- 3043709871
- 3045063937
- 3017415521
- 3043348029
- 3030748032
- 3013851422
- 3010520951
- 3016446653
- 3004167072
- 3016413636
- 2087361
- 3007361893
- 3014686987
- 3003539879
- 3013566770
- 3013730933
- 3001431138
- 3034204485
- 3015468814
- 3039346136
- 3019510795
- 3017177487
- 9710580
- 3021656665
- 3012512142
- 3013917867
- 3009488834
- 3008959444
- 3010097863
- 3012799115
- 3012017648
- 3005462245
- 3017887928
- 3018993530
- 3019570972
- 3011198715
- 3031595583
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 |
| 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 |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | 1995-08-02 |
Legacy Summary#
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
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