510(k) K801593
- Device
- LEBODY BY WATER PIK
- Applicant
- TELEDYNE, INC.
- 510(k) number
- K801593
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-08-20
- Date received
- 1980-07-14
- 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#
- 8043323
- 3012657194
- 3048973654
- 3025376109
- 3003062321
- 3010872518
- 3038284017
- 3043153468
- 3008806536
- 3035374295
- 3005405999
- 3033450607
- 3010626738
- 1061158
- 3013423303
- 3035641506
- 3014606355
- 3009435759
- 3010894709
- 3016460723
- 3016446653
- 3013503815
- 3027475369
- 3011539161
- 3026400760
- 3013057712
- 3014422258
- 3015504568
- 3006033709
- 3043140679
- 3010626066
- 3012110942
- 3038991271
- 3045063937
- 3006713791
- 9616868
- 3042255028
- 3013875443
- 3030650016
- 3006206425
- 3007740591
- 3018994233
- 3032948391
- 3018123168
- 3015967269
- 3009690509
- 3004126239
- 3016019469
- 3027851849
- 3015989868
- 3005095860
- 3017685521
- 3010297540
- 3010677917
- 3039388306
- 3013524663
- 3016170453
- 3004154499
- 3013733364
- 3016413636
- 3017149096
- 3027847726
- 3042261306
- 3004146401
- 2081228
- 3006707030
- 3039443706
- 3031980484
- 3017450375
- 3000163458
- 3035493196
- 3017357478
- 3040138099
- 3004839404
- 3013285519
- 3030498909
- 3016660845
- 3040807969
- 3021235806
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