510(k) K890923
- Device
- VITALON MATRESS MASSAGE MODEL M-MX
- Applicant
- NEXUS CO. LTD. C/O YAMA TRANS CO. LTD.
- 510(k) number
- K890923
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-14
- Date received
- 1989-02-24
- Regulation
- 890.5660
- Classification name
- Massager, Therapeutic, Electric
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- EIICHI YAMAMOTO
- Address
- 1-2-1-309 Ebisu-Nishi Shibuya-Ku, Tokyo Japan 150 ID
FDA Registration Numbers#
- 3017264244
- 3025104654
- 1063974
- 3005545844
- 3021635975
- 3014659326
- 3042194239
- 3008776869
- 3027631543
- 3010486573
- 2013558
- 3014847663
- 8043323
- 3015441062
- 3030465168
- 3010872518
- 3010027944
- 3009225905
- 3009212453
- 3016769192
- 3042070639
- 3000163458
- 3030488262
- 3043149902
- 3016171836
- 3006982887
- 3030748032
- 3031570300
- 3016618147
- 2431497
- 3026875458
- 3005238200
- 3042198580
- 3015527739
- 3013524663
- 3012477715
- 3014980461
- 1410825
- 3012008861
- 3030514805
- 3017618900
- 3006948534
- 3006066512
- 3042352420
- 3014977697
- 3035880570
- 3012547534
- 3043178619
- 3011108368
- 3016425406
- 3013180212
- 3043709874
- 3010677917
- 3019470217
- 3025702939
- 3013723028
- 3015522128
- 3045010480
- 3021316061
- 1000467313
- 3043572170
- 3000335748
- 3008756507
- 3027315350
- 3027483183
- 3017206625
- 3009862779
- 3038636181
- 3012386142
- 3014948462
- 3015487363
- 3019577501
- 3014101700
- 3015142940
- 3022553912
- 3019404876
- 3042256682
- 3017965926
- 3008753275
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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| 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