PBX · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-02-11 → 2026-07-10

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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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
Venus Concept USA, Inc.	3	0	2022-04-27
Capenergy Medical S.L.	3	1	2026-07-10
Viora , Ltd.	3	0	2020-12-09
Swims America Corp	3	0	2023-07-19
Weero Co., Ltd.	3	1	2026-03-13
Termosalud	2	0	2023-06-08
Heat IN A Click	2	0	2022-09-26
InMode , Ltd.	2	0	2024-11-14
Indiba S. A. U.	2	0	2025-01-24
Zimmer Medizinsysteme GmbH	2	0	2024-07-15
Shenzhen Leaflife Technology Co., Ltd.	1	0	2025-08-14
El.En Electronic Engineering Spa	1	0	2021-10-15
El.En S.P.A.	1	1	2026-04-02
Neauvia North America	1	0	2021-07-30
Cynosure, LLC	1	0	2020-03-25
General Vibronics, Inc.	1	0	2024-11-21
Novasonix Technology S.L.	1	0	2025-04-16
Globus Sport and Health Technologies, LLC	1	0	2022-06-06
Luvo Medical Technologies, Inc.	1	0	2021-07-20
Pollogen, Ltd.	1	1	2025-09-10
S&M Medical Co., Ltd.	1	1	2026-03-09
21 Equipment S.R.L.	1	0	2022-11-17
EMA Aesthetics , Ltd.	1	0	2025-04-15
Xod, Inc.	1	0	2025-02-27

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
2026-07-10	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
2023-03-01	K220014	Swims America Corp	RSHOCK

PBX · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances