510(k) K924237
- Device
- WINDMERE PRELUDE III
- Applicant
- WINDMERE CORP.
- 510(k) number
- K924237
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-10-18
- Date received
- 1992-08-24
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEE EICHENBERGER
- Address
- 5980 Miami Lades Dr. Miami Lakes FL US 33014 33014
FDA Registration Numbers#
- 3025376109
- 3018360321
- 3006620134
- 3018317166
- 3015217632
- 3038284017
- 3004096429
- 3016159413
- 3010852191
- 3043515268
- 3003015433
- 3014157870
- 3019491524
- 3017619615
- 3022553912
- 3003755374
- 3019401423
- 3010520951
- 3015457586
- 3045077467
- 3019864920
- 3015972751
- 3010626066
- 3011962812
- 3004450661
- 3040278125
- 3012289707
- 3026264
- 3017357478
- 3032948391
- 3010008676
- 3015738761
- 3016452327
- 3016171836
- 3012841710
- 3009617411
- 3042255028
- 3018455773
- 3009972291
- 9680222
- 3016879560
- 9616309
- 3017429279
- 2032513
- 3016071154
- 3021380980
- 3017149096
- 3040138099
- 3013723028
- 3007744197
- 3021594345
- 3030186811
- 3023339107
- 3009079475
- 3027475369
- 3035732161
- 3013057712
- 3027520359
- 3016019469
- 3012729332
- 3036779619
- 3011150256
- 3010364599
- 3020977186
- 3026319046
- 3012316249
- 1063974
- 3014948462
- 3029972544
- 3027851849
- 3018123168
- 3007084556
- 3007766590
- 3010673773
- 3020284548
- 3009616415
- 3038641388
- 3009406433
- 3033905868
Source Documents#
510(k) summary PDF not indicated by FDA
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