510(k) K944730
- Device
- MASSAGER
- Applicant
- NORTH AMERICAN TECHNICAL SERVICES CORP.
- 510(k) number
- K944730
- Product code
- ISA
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1995-02-14
- Date received
- 1994-09-26
- 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
- RICHARD C LANZILLOTTO
- Address
- 30 Northport Rd. Sound Beach NY US 11789 11789
FDA Registration Numbers#
- 3007731000
- 3017202440
- 3010027944
- 3019401423
- 3043149162
- 3032520456
- 3006610790
- 3033850489
- 3035493196
- 3042261306
- 9710609
- 2011068
- 3027341451
- 3014422258
- 3034288049
- 3000099306
- 3027520359
- 3013662621
- 3033647470
- 3018360321
- 3027601982
- 3009278339
- 3017222105
- 3010290186
- 3004450661
- 3003755374
- 3016994791
- 3044859436
- 3003851819
- 3038991271
- 3029150933
- 3020284548
- 3017866840
- 3033883954
- 3030650016
- 3043138914
- 3044519321
- 3012840029
- 3015337391
- 3007645866
- 3004756871
- 3005551496
- 3025665471
- 3007008050
- 3045010480
- 3042276319
- 3013517454
- 3027605322
- 9611102
- 3008585473
- 3010168323
- 3014847663
- 3008929787
- 3017406171
- 3003590412
- 3010547367
- 3014700242
- 3012477715
- 3015968545
- 2032513
- 3038622006
- 3014978308
- 3038284017
- 3004624259
- 3017060146
- 3015504237
- 3002849858
- 3007145088
- 3030970133
- 3009889060
- 3046007041
- 3031238386
- 3031944951
- 3011423170
- 3005200548
- 3024379416
- 3011298181
- 3033918960
- 3017961176
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