PBX · Massager, Vacuum, Radio Frequency Induced Heat

Device class

Class II

Regulation 878.4400

Total clearances

2020-02-11 → 2026-09-22

Last 12 months

Unique sponsors

Definition

What is Massager, Vacuum, Radio Frequency Induced Heat

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4400

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Bios S.R.L.	4	0	2023-10-30
Weero Co., Ltd.	3	1	2026-03-13
Viora , Ltd.	3	0	2020-12-09
Swims America Corp	3	0	2023-07-19
Capenergy Medical S.L.	3	1	2026-07-10
Venus Concept USA, Inc.	3	0	2022-04-27
InMode , Ltd.	2	0	2024-11-14
Termosalud	2	0	2023-06-08
Zimmer Medizinsysteme GmbH	2	0	2024-07-15
Indiba S. A. U.	2	0	2025-01-24
Heat IN A Click	2	0	2022-09-26
21 Equipment S.R.L.	1	0	2022-11-17
Bh Group Us, LLC	1	1	2026-09-22
Neauvia North America	1	0	2021-07-30
Shenzhen Leaflife Technology Co., Ltd.	1	0	2025-08-14
CAO Group, Inc.	1	0	2020-10-28
Termosalud S.L.	1	0	2025-05-28
Novasonix Technology S.L.	1	0	2025-04-16
Mectronic Medicale S.R.L.	1	0	2023-02-17
EMA Aesthetics , Ltd.	1	0	2025-04-15
Golden Star Srl	1	0	2024-12-26
General Vibronics, Inc.	1	0	2024-11-21
Xod, Inc.	1	0	2025-02-27
El.En S.P.A.	1	1	2026-04-02
El.En Electronic Engineering Spa	1	0	2021-10-15

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
97032	CPT	—	Medium	Therapeutic modality; application of modality (heat/massage) for pain relief
A4595	HCPCS	Electrical stimulator supplies, 2 lead, per month, (e.g., tens, nmes) ✓ CMS-verified description	Low	Electrical stimulation device supplies; may apply if device components are billable separately

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-22	K243223	Bh Group Us, LLC	Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
2026-07-10	K253480	Capenergy Medical S.L.	Capenergy C Equipments RF C200 and C400 Drakarian
2026-04-02	K260647	El.En S.P.A.	SPECCHIO
2026-03-13	K253261	Weero Co., Ltd.	Apollo Quattro (APQ-10M)
2026-03-09	K252888	S&M Medical Co., Ltd.	NeoSculpt Plus
2025-09-10	K250734	Pollogen, Ltd.	OptiLUV Device
2025-08-14	K250916	Shenzhen Leaflife Technology Co., Ltd.	WinForth (LM-E470KA)
2025-05-28	K243716	Termosalud S.L.	Zionic Pro Max (Radiofrequency)
2025-04-16	K241733	Novasonix Technology S.L.	HEBE (NP0000763)
2025-04-15	K243055	EMA Aesthetics , Ltd.	Préime DermaFacial Collagen+
2025-02-27	K242175	Xod, Inc.	XOD Diathermia Radiofrequency Device
2025-01-24	K241107	Indiba S. A. U.	Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
2024-12-26	K232966	Golden Star Srl	FISIOWARM 7.0
2024-11-21	K242553	General Vibronics, Inc.	MIRARI® Cold Plasma System ( GV-M2-01)
2024-11-20	K243164	Indiba S. A. U.	INDIBA COMPACT devices
2024-11-14	K242598	InMode , Ltd.	DEFINE System (AG612444A)
2024-10-09	K240991	Weero Co., Ltd.	eMVFit (MVF-10M)
2024-07-15	K240178	Zimmer Medizinsysteme GmbH	RFG-01
2023-10-30	K230755	Bios S.R.L.	NuEra Tight RF Model OptiStream
2023-07-19	K230037	Swims America Corp	BACK 3
2023-06-08	K230659	Termosalud	Zionic Aesthetic
2023-05-25	K213256	Zimmer Medizinsysteme GmbH	ThermoTK
2023-05-02	K223907	Bios S.R.L.	NuEra Tight RF Model APMD145.M70-US
2023-04-13	K230412	Termosalud	Symmed Elite Aesthetic
2023-03-28	K222260	Capenergy Medical S.L.	Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500