510(k) K852944
- Device
- FLEXIMATIC MASSAGER
- Applicant
- GENERAL PHYSIOTHERAPY, INC.
- 510(k) number
- K852944
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-05
- Date received
- 1985-07-11
- 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
- THOMAS P MUCHISKY
- Address
- 1520 Washington Ave. St. Louis MO US 63103 63103
FDA Registration Numbers#
- 3021393315
- 9616309
- 3010852191
- 3019864920
- 3007740591
- 3026038437
- 3016618147
- 3033850489
- 3010402752
- 2249769
- 3030970133
- 3010595915
- 3014471045
- 3013562453
- 3043712145
- 3019510795
- 9616868
- 3013395414
- 3014948462
- 3022066208
- 3025936823
- 3019705154
- 3014664380
- 2432177
- 3009079475
- 3023326918
- 3014442295
- 3027436335
- 2032513
- 3017152329
- 3018455773
- 3030541417
- 3012772112
- 3012840029
- 3030543531
- 3004006265
- 3017618922
- 3014101700
- 3013503815
- 3017435733
- 3015499445
- 3008585473
- 3008048783
- 3020887108
- 3004412274
- 3016731115
- 3025414368
- 3038195193
- 3027645761
- 3026319046
- 3010486573
- 1648564
- 3013440654
- 3044461452
- 3026322014
- 3042940354
- 9710514
- 3018125923
- 3019470217
- 3021594345
- 3029897009
- 3017494274
- 3014159202
- 3034969990
- 3009225484
- 3027631543
- 3016071154
- 3043748811
- 1217805
- 3005462245
- 3013723028
- 3010097863
- 3013671142
- 3021593882
- 3014847663
- 3017618900
- 3005980667
- 3042198626
- 3043496871
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