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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2026 | Therabody, Inc Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO charger.
G4 PRO Black US - Refurb., SKU TG02428-01
G4 PRO NA, SKU G4-PRO-PKG-NA
Open, Classified |
ISA | None listed |
| Nov 24, 2025 | Pivotal Health Solutions, Inc. Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table Open, Classified |
ISA | None listed |
| Nov 24, 2025 | Pivotal Health Solutions, Inc. Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table Open, Classified |
ISA | None listed |
| May 13, 2025 | Richard Wolf GmbH PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager). Open, Classified |
ISA | None listed |
| Feb 5, 2021 | Wahl Clipper Corp WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains. Terminated |
ISA | None listed |
| Nov 10, 2011 | King International Shoulder Flex Massage Device
Device is an electric personal massage device labeled in part: "ShoulderFlex Deep-kneading Shiatsu* Model #SH61 *Read all instructions before using the massager* **WAR Terminated |
ISA | None listed |
| Jun 23, 2009 | Sybaritic, Inc Sybaritic, Inc., SlimLine Health Environment Capsule,
a dry heat body chamber with facial and body chamber LED panels. Terminated |
ISA | None listed |
| Jan 26, 2006 | Wahl Clipper Corp Wahl 2-Speed All-Body Massager with Heat and Discovery Channel brand 8-Way Massager with Heat, model 4196-1; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China;
Please Terminated |
ISA | None listed |
| Jan 26, 2006 | Wahl Clipper Corp Wahl 2-Speed All-Body Massager, model 4120-1; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China;
Please note: Wahl sells these massagers under other model numbers base Terminated |
ISA | None listed |
| Jun 1, 2005 | Wahl Clipper Corp Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Wahl Clipper Corporation, Sterling, IL 61081, made in China Terminated |
ISA | None listed |
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