510(k) K932904
- Device
- WINDMERE WAND MASSAGER
- Applicant
- WINDMERE CORP.
- 510(k) number
- K932904
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-17
- Date received
- 1993-06-16
- 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#
- 3022066208
- 3027436335
- 2432177
- 3027483183
- 3003446042
- 3012316249
- 3013503862
- 3045925752
- 3019401423
- 1063974
- 3017415521
- 3014344059
- 3015195058
- 3040985888
- 3005200548
- 3010334650
- 3014133483
- 3005695724
- 3043126945
- 3009068676
- 3017618900
- 3016460723
- 3013057712
- 3017429279
- 3013524663
- 3043729001
- 3015989868
- 3043655600
- 3024555465
- 3016019469
- 1418479
- 3011564440
- 3015441062
- 3021594345
- 3018995133
- 3022375842
- 3010595915
- 3008806536
- 9710514
- 3013521677
- 9616868
- 3010894709
- 3013903013
- 2087361
- 3045323136
- 3009155917
- 3033850491
- 3014101700
- 3012341715
- 3013517454
- 3038622006
- 3017910381
- 3029983584
- 3043729112
- 3001676837
- 3004167072
- 3019404876
- 3011782009
- 1926174
- 3024379416
- 3009103076
- 3014449259
- 3016159364
- 3042276479
- 1062240
- 3004146401
- 3013579894
- 3044989687
- 3009156060
- 3043515268
- 3042261306
- 3015504237
- 3043748811
- 3017866840
- 3004938911
- 3025421718
- 3040389273
- 3018259873
- 2953684
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ISA #
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|---|---|---|---|
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| 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