ISA — Massager, Therapeutic, Electric Class I
FDA Device Classification
Classification Details
- Product Code
- ISA
- Device Class
- Class I
- Regulation Number
- 890.5660
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243488 | termosalud | VMAT PRO | February 6, 2025 |
| K240358 | shenzhen dongdixin technology co | ShockPhysio Mobile (model SW3200 Basic) | June 5, 2024 |
| K221865 | btl industries | BTL-094 | April 14, 2023 |
| K210166 | medispec | Omnispec ED1000 | January 27, 2023 |
| K213120 | tissue regeneration technologies, llc dba as softwave trt | OW100S (model OW100S-US) | October 12, 2022 |
| K220538 | e.m.s electro medical systems | DolorClast Radial | July 11, 2022 |
| K210451 | tissue regeneration technologies | OrthoGold 100 | May 5, 2021 |
| K182682 | tissue regeneration technologies | OrthoGold 100 | December 21, 2018 |
| K173692 | storz medical | D-Actor 200 Vibration Massage System | April 13, 2018 |
| K053225 | lpg one | CELLU M6 KEYMODULE I | November 6, 2006 |
| K030876 | cynosure | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | January 22, 2004 |
| K002908 | jet therapy | JET THERAPY | August 30, 2001 |
| K990445 | lpg usa | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | January 18, 2000 |
| K952990 | kinsei shiatsu | SPIN ROLLERE | September 29, 1995 |
| K952041 | truro ent | BODYFLEX MASSAGER | August 14, 1995 |
| K950411 | kinsei shiatsu | RELAXU-1 | August 2, 1995 |
| K950931 | siegel,mandell and davidson,p.c | AVON MASSAGING HAIRBRUSH | April 5, 1995 |
| K950655 | ultrassage | THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES | March 7, 1995 |
| K950322 | kinsei shiatsu | RELAXY-THE WONDER HAND | February 14, 1995 |
| K944884 | kolvin industries | DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B | February 14, 1995 |