Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5660](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5660) → ISA — Massager, Therapeutic, Electric # ISA · Massager, Therapeutic, Electric _Physical Medicine · 21 CFR 890.5660 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA ## Overview - **Product Code:** ISA - **Device Name:** Massager, Therapeutic, Electric - **Regulation:** [21 CFR 890.5660](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5660) - **Device Class:** 1 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. ## Recent Cleared Devices (20 of 100) Showing 20 most recent of 100 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243488](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K243488.md) | VMAT PRO | Termosalud | Feb 6, 2025 | SESE | | [K240358](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K240358.md) | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | Jun 5, 2024 | SESE | | [K221865](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K221865.md) | BTL-094 | BTL Industries, Inc. | Apr 14, 2023 | SESE | | [K210166](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K210166.md) | Omnispec ED1000 | Medispec, Ltd. | Jan 27, 2023 | SESE | | [K213120](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K213120.md) | OW100S (model OW100S-US) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | Oct 12, 2022 | SESE | | [K220538](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K220538.md) | DolorClast Radial | E.M.S Electro Medical Systems S.A | Jul 11, 2022 | SESE | | [K210451](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K210451.md) | OrthoGold 100 | Tissue Regeneration Technologies, LLC | May 5, 2021 | SESE | | [K182682](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K182682.md) | OrthoGold 100 | Tissue Regeneration Technologies | Dec 21, 2018 | SESE | | [K173692](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K173692.md) | D-Actor 200 Vibration Massage System | Storz Medical AG | Apr 13, 2018 | SESE | | [K053225](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K053225.md) | CELLU M6 KEYMODULE I | Lpg One, Inc. | Nov 6, 2006 | SESE | | [K030876](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K030876.md) | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | Cynosure, Inc. | Jan 22, 2004 | SESE | | [K002908](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K002908.md) | JET THERAPY | Jet Therapy | Aug 30, 2001 | SESE | | [K990445](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K990445.md) | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | Lpg USA, Inc. | Jan 18, 2000 | SESE | | [K952990](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K952990.md) | SPIN ROLLERE | Kinsei Shiatsu, Inc. | Sep 29, 1995 | SN | | [K952041](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K952041.md) | BODYFLEX MASSAGER | Truro'S Ent. | Aug 14, 1995 | SESE | | [K950411](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K950411.md) | RELAXU-1 | Kinsei Shiatsu, Inc. | Aug 2, 1995 | SESE | | [K950931](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K950931.md) | AVON MASSAGING HAIRBRUSH | Siegel,Mandell & Davidson,P.C. | Apr 5, 1995 | SN | | [K950655](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K950655.md) | THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES | Ultrassage, Inc. | Mar 7, 1995 | SN | | [K950322](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K950322.md) | RELAXY-THE WONDER HAND | Kinsei Shiatsu, Inc. | Feb 14, 1995 | SN | | [K950321](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA/K950321.md) | SHAPE UP MOMI ROLLER | Kinsei Shiatsu, Inc. | Feb 14, 1995 | SN | ## Top Applicants - Conair Corp. — 10 clearances - General Physiotherapy, Inc. — 5 clearances - Kinsei Shiatsu, Inc. — 5 clearances - Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. — 3 clearances - Omron Healthcare, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ISA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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