510(k) K990445
- Device
- LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
- Applicant
- LPG USA, INC.
- 510(k) number
- K990445
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-18
- Date received
- 1999-02-10
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOCELYNE ROLLAND
- Address
- 3101 N. Federal Hwy. #300 Fort Lauderdale FL US 33306 33306
FDA Registration Numbers#
- 3010894709
- 3017202440
- 3031595583
- 3012113199
- 3014326210
- 3016731115
- 3033884638
- 3019015047
- 3024838923
- 3023850562
- 3030465168
- 3017837510
- 3015738761
- 3030970133
- 3008643402
- 3020887108
- 3017177487
- 3005033444
- 3006610790
- 3015337391
- 3013501525
- 3011644607
- 3006624940
- 3000335748
- 3009156060
- 3043729621
- 8043323
- 3033435469
- 3003015433
- 3038166027
- 3027520359
- 3045323136
- 3034733556
- 3017429279
- 3016170451
- 3005095860
- 2311923
- 3016661538
- 3015286916
- 2953684
- 3021282523
- 3021177911
- 1000164900
- 3027436335
- 3012841710
- 3016618147
- 3030186811
- 3003755374
- 3011260865
- 8010720
- 3013846071
- 3014388884
- 3018502801
- 3005170249
- 3021235142
- 3014345255
- 3048286500
- 3014164578
- 3014980461
- 3017060146
- 9611558
- 3012840029
- 3008929787
- 3046314381
- 3016915446
- 3003062321
- 3017618900
- 3043140693
- 3022192
- 3005551496
- 3016769192
- 3018360321
- 3009684923
- 3019470217
- 3009068676
- 3006206425
- 3023339107
- 3014158749
- 2081228
Source Documents#
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 |
| K952990 | SPIN ROLLERE | Kinsei Shiatsu, Inc. | 1995-09-29 |
| K952041 | BODYFLEX MASSAGER | Truro'S Ent. | 1995-08-14 |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | 1995-08-02 |
Legacy Summary#
summary
FDA Review#
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