Panels › Physical Medicine › Product code ISA · Class 1
Massager, Therapeutic, Electric
Regulation 890.5660
0510(k)s in 12 months (100 all time)
3recalls in 12 months (10 all time)
0recalls that name a 510(k)
Top companies in ISA
| Company | 510(k)s | Recalls |
|---|---|---|
| Conair Corp. | 10 | 0 |
| Wahl Clipper Corp. | 3 | 4 |
| General Physiotherapy, Inc. | 5 | 0 |
| Kinsei Shiatsu, Inc. | 5 | 0 |
| Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. | 3 | 0 |
| Omron Healthcare, Inc. | 3 | 0 |
| Kolvin Industries , Ltd. | 2 | 0 |
| Pivotal Health Solutions, Inc. | 0 | 2 |
| Tissue Regeneration Technologies | 2 | 0 |
| Westminster International Co., Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2025 | K243488 | VMAT PRO Termosalud, ES | ISA |
| Jun 5, 2024 | K240358 | ShockPhysio Mobile (model SW3200 Basic) Shenzhen Dongdixin Technology Co., Ltd., CN | ISA |
| Apr 14, 2023 | K221865 | BTL-094 BTL Industries, Inc. | ISA |
| Jan 27, 2023 | K210166 | Omnispec ED1000 Medispec, Ltd. | ISA |
| Oct 12, 2022 | K213120 | OW100S (model OW100S-US) Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | ISA |
| Jul 11, 2022 | K220538 | DolorClast Radial E.M.S Electro Medical Systems S.A, CH | ISA |
| May 5, 2021 | K210451 | OrthoGold 100 Tissue Regeneration Technologies, LLC | ISA |
| Dec 21, 2018 | K182682 | OrthoGold 100 Tissue Regeneration Technologies | ISA |
| Apr 13, 2018 | K173692 | D-Actor 200 Vibration Massage System Storz Medical AG, CH | ISA |
| Nov 6, 2006 | K053225 | CELLU M6 KEYMODULE I Lpg One, Inc. | ISA |
| Jan 22, 2004 | K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM Cynosure, Inc. | ISA |
| Aug 30, 2001 | K002908 | JET THERAPY Jet Therapy | ISA |
| Jan 18, 2000 | K990445 | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR Lpg USA, Inc. | ISA |
| Sep 29, 1995 | K952990 | SPIN ROLLERE Kinsei Shiatsu, Inc. | ISA |
| Aug 14, 1995 | K952041 | BODYFLEX MASSAGER Truro'S Ent., CA | ISA |
| Aug 2, 1995 | K950411 | RELAXU-1 Kinsei Shiatsu, Inc. | ISA |
| Apr 5, 1995 | K950931 | AVON MASSAGING HAIRBRUSH Siegel,Mandell & Davidson,P.C. | ISA |
| Mar 7, 1995 | K950655 | THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES Ultrassage, Inc., CA | ISA |
| Feb 14, 1995 | K950322 | RELAXY-THE WONDER HAND Kinsei Shiatsu, Inc. | ISA |
| Feb 14, 1995 | K950321 | SHAPE UP MOMI ROLLER Kinsei Shiatsu, Inc. | ISA |
| Feb 14, 1995 | K950320 | RELAXY-WONDER KNOCK Kinsei Shiatsu, Inc. | ISA |
| Feb 14, 1995 | K944885 | DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 Kolvin Industries , Ltd., HK | ISA |
| Feb 14, 1995 | K944884 | DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B Kolvin Industries , Ltd., HK | ISA |
| Feb 14, 1995 | K944730 | MASSAGER North American Technical Services Corp. | ISA |
| Jan 18, 1995 | K936178 | AGILANCE-GOLDEN SPOONS Oismuller & Partner Keg, AT | ISA |
| Dec 13, 1994 | K944637 | FAMILY FITNESS SHIATSU MASSAGER Conair Corp. | ISA |
| Dec 8, 1994 | K944024 | STIMU-TAP Wahl Clipper Corp. | ISA |
| Sep 29, 1994 | K943092 | FAMILY FITNESS SHIATSU MASSAGER Conair Corp. | ISA |
| Jul 26, 1994 | K942950 | BODY FLEX Conair Corp. | ISA |
| Jun 22, 1994 | K942218 | SHIATSU MASSAGER Westminster International Co., Inc. | ISA |
| Jun 22, 1994 | K940621 | PRO-SHIATSU PORTABLE MASSAGER Westminster International Co., Inc. | ISA |
| Jun 9, 1994 | K942223 | BODY SYSTEM Conair Corp. | ISA |
| Jun 9, 1994 | K941594 | WAHL DOUBLE COMFORT MASSAGER Wahl Clipper Corp. | ISA |
| Jun 9, 1994 | K940683 | WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA Wahl Clipper Corp. | ISA |
| Apr 21, 1994 | K940543 | MODEL 777 THERAPEUTIC MASSAGER Voyager Medical Corp. | ISA |
| Apr 21, 1994 | K940369 | BODY RECHARGER Conair Corp. | ISA |
| Mar 30, 1994 | K925907 | AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER Pollenex Corp. | ISA |
| Mar 28, 1994 | K931636 | FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER Fairform Mfg., Co., Ltd., HK | ISA |
| Mar 4, 1994 | K935581 | OMRON MASSAGER MODEL HM-102 Omron Healthcare, Inc. | ISA |
| Mar 4, 1994 | K935462 | OMBRON TWIN-HEAD MASSAGER MODEL HM-101 Omron Healthcare, Inc. | ISA |
| Mar 4, 1994 | K935459 | OMRON MASSAGER MODEL HM-45 Omron Healthcare, Inc. | ISA |
| Mar 4, 1994 | K926339 | BODY RELAXER Conair Corp. | ISA |
| Feb 25, 1994 | K911727 | INFRADERM; TOUCH 'N TONE PLUS Conair Corp. | ISA |
| Feb 17, 1994 | K932904 | WINDMERE WAND MASSAGER Windmere Corp. | ISA |
| Oct 18, 1993 | K924237 | WINDMERE PRELUDE III Windmere Corp. | ISA |
| Oct 12, 1993 | K924518 | BODY SOOTHER Conair Corp. | ISA |
| Sep 30, 1993 | K924520 | BODY TRAINER Conair Corp. | ISA |
| Jun 29, 1993 | K925036 | HANDY VIBRO BELT Cosmesearch, Inc. | ISA |
| Jun 24, 1993 | K923541 | BODY-MATE MASSAGER American Therapy Products | ISA |
| Mar 31, 1993 | K921000 | SONACARE SOUND MASSAGER Honor Trading, Ltd. | ISA |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.