510(k) K842802
- Device
- VACOMED 4
- Applicant
- ROBERT BOSCH CORP.
- 510(k) number
- K842802
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-01
- Date received
- 1984-07-17
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3020977186
- 3018448099
- 3034204485
- 3026264
- 3006737652
- 3017488811
- 3015337391
- 3030488262
- 3044859436
- 3006546131
- 3008929787
- 3034731361
- 3017887928
- 3013733364
- 3012008861
- 3043654467
- 3013566770
- 3000335748
- 3016951909
- 3015131233
- 9710580
- 3013917867
- 3000163458
- 3011150256
- 3006713791
- 3042198626
- 3030543531
- 3023613474
- 3032171377
- 3002807616
- 3040278125
- 3043140693
- 3039080630
- 3012833018
- 3014139817
- 3033918960
- 3017265430
- 3009212453
- 3013735158
- 3011191255
- 2431497
- 3027631543
- 3005740303
- 3027436335
- 3014980461
- 3043729621
- 3031232993
- 3016717521
- 3008756507
- 3015165898
- 3021235806
- 3045077467
- 3014159202
- 3026320075
- 3005651859
- 3005405999
- 3020311934
- 3027328721
- 3045323136
- 3026875458
- 3009915339
- 3015217632
- 3031595583
- 3013180212
- 3043011436
- 3035641506
- 3037609256
- 3030412027
- 3017262714
- 3021282523
- 2011068
- 3007439125
- 3012512142
- 3006707030
- 3017150671
- 3012477715
- 3009103076
- 3012657194
- 3020750249
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#
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