510(k) K952990
- Device
- SPIN ROLLERE
- Applicant
- KINSEI SHIATSU, INC.
- 510(k) number
- K952990
- Product code
- ISA
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1995-09-29
- Date received
- 1995-06-28
- 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
- HARU ISHIMOTO
- Address
- 22138 S. Vermont Ave. Unit F Torrance CA US 90502 90502
FDA Registration Numbers#
- 3045077467
- 3012477715
- 3012217421
- 3014442295
- 3013689783
- 3016460723
- 3011070163
- 3021235142
- 3026870393
- 3045063919
- 3007361893
- 3013503815
- 3031583032
- 3029150933
- 3040278125
- 3045063937
- 3033530347
- 3030748032
- 3004126239
- 3027057394
- 3005200548
- 3027475369
- 3018455773
- 1055758
- 3035641506
- 3017450375
- 3010724743
- 3007816986
- 3025428426
- 3018269960
- 1217805
- 3014157870
- 3042278063
- 3010027944
- 3009862779
- 3034995492
- 3048248118
- 3043153468
- 3009406433
- 3014601569
- 3043712145
- 3013501525
- 3015494742
- 3012316249
- 1222304
- 3015195058
- 3043729112
- 2087361
- 3011149139
- 3043127589
- 3017103444
- 3015499375
- 3027692296
- 3010555871
- 3018981015
- 3043012240
- 3017555752
- 3030412027
- 3043126945
- 3029897009
- 3030970133
- 3017149096
- 3043572170
- 3038991271
- 3040138099
- 3016170453
- 3018448099
- 3045978226
- 3010364599
- 3016458459
- 3017965926
- 3011170521
- 3008753275
- 3017199830
- 3039210948
- 3009690509
- 3017936791
- 3000335748
- 3009952847
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 |
| 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