Product code ISA
- Device name
- Massager, Therapeutic, Electric
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5660
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | 1995-08-02 |
| K950931 | AVON MASSAGING HAIRBRUSH | Siegel,Mandell & Davidson,P.C. | 1995-04-05 |
| K950655 | THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES | Ultrassage, Inc. | 1995-03-07 |
| K950322 | RELAXY-THE WONDER HAND | Kinsei Shiatsu, Inc. | 1995-02-14 |
| K950321 | SHAPE UP MOMI ROLLER | Kinsei Shiatsu, Inc. | 1995-02-14 |
| K950320 | RELAXY-WONDER KNOCK | Kinsei Shiatsu, Inc. | 1995-02-14 |
| K944885 | DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 | Kolvin Industries , Ltd. | 1995-02-14 |
| K944884 | DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B | Kolvin Industries , Ltd. | 1995-02-14 |
| K944730 | MASSAGER | North American Technical Services Corp. | 1995-02-14 |
| K936178 | AGILANCE-GOLDEN SPOONS | Oismuller & Partner Keg | 1995-01-18 |
| K944637 | FAMILY FITNESS SHIATSU MASSAGER | Conair Corp. | 1994-12-13 |
| K944024 | STIMU-TAP | Wahl Clipper Corp. | 1994-12-08 |
| K943092 | FAMILY FITNESS SHIATSU MASSAGER | Conair Corp. | 1994-09-29 |
| K942950 | BODY FLEX | Conair Corp. | 1994-07-26 |
| K942218 | SHIATSU MASSAGER | Westminster International Co., Inc. | 1994-06-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16973368290059 | Medisana | Zhangzhou Easepal Medical Science And Technology Co., Ltd. | 2026-04-30 |
| 07630039101855 | MASTERPULS® | Storz Medical AG | 2026-04-15 |
| 08034108512679 | Plus Handpiece | DEKA M.E.L.A. SRL | 2025-10-22 |
| 08800205600003 | Neuclare | Deepsonbio Co., Ltd | 2025-08-08 |
| 08809643652087 | CERAGEM Master V9 | CERAGEM Co., Ltd. | 2025-07-15 |
| 08800066190026 | Plason | SeoulinMedicare Co.,Ltd. | 2022-05-27 |
| 08809540050023 | Plasma shower | SeoulinMedicare Co.,Ltd. | 2022-05-27 |
| 17290110122192 | Glide Disposable Tip (x1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122154 | Opus Colibri 0.7mm Single-use Tip Set (X6) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122161 | Opus Colibri 1mm Single-use Tip Set (X6) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122178 | Opus Colibri 0.7mm Single-use Tip (X1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122185 | Opus Colibri 1mm Single-use Tip (X1) | ALMA LASERS LTD. | 2021-11-14 |
| 17290110122208 | Glide Disposable Tip Set (X12) | ALMA LASERS LTD. | 2021-11-14 |
| 07630039101404 | DUOLITH® | Storz Medical AG | 2021-06-29 |
| 17290110122086 | Opus Plasma Applicator | ALMA LASERS LTD. | 2021-01-25 |
| 17290110121782 | Opus System 110V | ALMA LASERS LTD. | 2020-02-20 |
| 17290110121805 | Opus Plasma HP/Applicator | ALMA LASERS LTD. | 2020-02-17 |
| 17290110121768 | Accent Elite System 110V (Black) | ALMA LASERS LTD. | 2019-12-31 |
| 17290110121775 | RF Pixel HP for Accent Elite System (110V) | ALMA LASERS LTD. | 2019-12-31 |
| B311PEPEAK0 | PURE ENRICHMENT | BEAR DOWN CONSULTING | 2019-11-15 |
| 17290110121690 | Mini Speed HP | ALMA LASERS LTD. | 2019-03-24 |
| 17290110121683 | Accent system | ALMA LASERS LTD. | 2019-03-08 |
| 17290110121614 | Unipolar HP | ALMA LASERS LTD. | 2018-08-22 |
| 17290110121607 | Bipolar HP | ALMA LASERS LTD. | 2018-08-22 |
| 17290016627685 | Silk'n | HOME SKINOVATIONS LTD | 2018-06-11 |
| 17290016627678 | Silk'n | HOME SKINOVATIONS LTD | 2018-06-11 |
| 17290016627661 | Silk'n | HOME SKINOVATIONS LTD | 2018-05-27 |
| 07640161462014 | BEMER Therapy Systems | Bemer Int. AG | 2017-05-03 |
| B556HY7000U0 | Migun | MIGUN LIFE CO., LTD | 2017-05-01 |
| B344HY7000U0 | Migun | MIGUN LIFE INC | 2017-02-11 |