510(k) K210451
- Device
- OrthoGold 100
- Applicant
- Tissue Regeneration Technologies, LLC
- 510(k) number
- K210451
- Product code
- ISA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-05
- Date received
- 2021-02-16
- 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
- John Warlick
- Address
- 251 Heritage Walk Woodstock GA US 30188 30188
FDA Registration Numbers#
- 3015063984
- 3032903908
- 3033273466
- 3030650016
- 3005462245
- 3044918836
- 3016159364
- 3006737652
- 3030498909
- 3020978012
- 3012386142
- 3025376109
- 3014978308
- 3031238386
- 3043729119
- 3043138914
- 3007278668
- 3020900954
- 9617420
- 3038369467
- 3042278063
- 3043729621
- 3017866840
- 3014345255
- 3009072217
- 3015972751
- 3005095860
- 3011782009
- 3016831175
- 3014388884
- 3045978226
- 3008361502
- 3008770708
- 3014659326
- 3011258423
- 3015972776
- 3019577501
- 3030186176
- 3009495876
- 3013846071
- 3032520456
- 3017961176
- 3040314796
- 3043655600
- 3033647470
- 3006891384
- 3014539793
- 3008643402
- 3016170453
- 3015536186
- 1648564
- 3027645761
- 3007962592
- 3022192
- 3015005470
- 3033883954
- 3044777131
- 3016458380
- 3013503862
- 3019604555
- 1832894
- 3015967269
- 3022028624
- 9710567
- 3006620134
- 3026182452
- 3013875443
- 3015009277
- 3006624940
- 3018502801
- 3030214027
- 3000335748
- 3002849858
- 3038320370
- 3020311934
- 3027851849
- 3027341447
- 3004167072
- 3009736547
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 |
| 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 |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | 1995-08-02 |
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