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#
- 3037003917
- 3018070318
- 3006479639
- 3011654863
- 3017357478
- 3010290186
- 3014449259
- 3032948391
- 3016831175
- 3035371866
- 2134295
- 3043655600
- 3012725363
- 3016678950
- 3025104654
- 3016170451
- 3010890287
- 3010334650
- 3011209790
- 3016994791
- 3030358449
- 3009557417
- 3027436335
- 3027328721
- 3045978226
- 3013077196
- 3009072217
- 3006546131
- 3013735158
- 3013503862
- 3017685521
- 3004154499
- 3009155917
- 3043654467
- 3006206425
- 3013423303
- 3026182452
- 3010785927
- 3035641506
- 3009428929
- 9710567
- 3009435759
- 3015441062
- 3018995133
- 3015338588
- 3014561131
- 3025702939
- 3005587124
- 3005630901
- 3007766590
- 3014601569
- 3043012074
- 3017406171
- 3017488811
- 3017153262
- 3013517454
- 8022890
- 1222304
- 3015527739
- 3010097863
- 3013180212
- 1648564
- 3006624940
- 3005170249
- 3039389294
- 3011198715
- 9616309
- 3029338825
- 3009129782
- 2013558
- 3016458380
- 3021177911
- 3043012240
- 3003238222
- 3030214027
- 3015165898
- 3038195193
- 3013924508
- 3017264244
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