510(k) K942223
- Device
- BODY SYSTEM
- Applicant
- CONAIR CORP.
- 510(k) number
- K942223
- Product code
- ISA
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1994-06-09
- Date received
- 1994-05-06
- 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
- JEFFREY A WORD
- Address
- 1 Cummings Pt. Rd. Stamford CT US 06904 06904
FDA Registration Numbers#
- 3013423303
- 3010310816
- 3013077196
- 3017618922
- 3014561131
- 3045925755
- 3016661538
- 3008437606
- 3037003917
- 3043729001
- 1000467313
- 3007048017
- 3022553912
- 2020958
- 3005980667
- 3027601982
- 3009072217
- 3016660845
- 3016170453
- 2953684
- 3011654863
- 3009617411
- 3012512142
- 3013510855
- 3016053560
- 1061158
- 3009406433
- 3019510795
- 3026400760
- 3044519321
- 3021380980
- 3027631543
- 3016159413
- 3025306332
- 3007816986
- 3017199830
- 3015738761
- 3015619973
- 3010402752
- 3045063919
- 3030214027
- 3039080630
- 3021334093
- 3008959444
- 3000099306
- 3017103444
- 3044859436
- 3015504568
- 3003539879
- 3016162044
- 3009942828
- 3008806536
- 3005405999
- 3046007041
- 3031570300
- 3033918960
- 3009523076
- 3042352420
- 3035371866
- 3013171945
- 3009889060
- 2249769
- 3010511300
- 3012017648
- 3019015047
- 3034995492
- 3013057712
- 3006362755
- 3014158749
- 3017961176
- 3005095860
- 3016074959
- 3017406171
- 3043012074
- 3012217421
- 3026322014
- 3042194239
- 2032513
- 3027436335
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