Chrysalis Intelligence · Product Codes · IPF

IPF · Stimulator, Muscle, Powered

Physical Medicine · 53 clearances · 43 unique sponsors

Device class
Class II
Regulation 890.5850
Total clearances
53
2020-01-11 → 2026-06-08
Last 12 months
4
Unique sponsors
43
Medical specialty
Physical Medicine
Review panel
PM
Regulation number
890.5850
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Firstkind Limited 3 0 2022-03-04
Weero Co., Ltd. 3 1 2026-06-08
BTL Industries, Inc. 2 0 2024-08-17
Ncs Lab Srl 2 0 2022-10-14
Smartmissimo Technologies Pte, Ltd. 2 0 2021-07-30
Mettler Electronics Corporation 2 0 2024-03-21
Cymedica Orthopedics, Inc. 2 0 2022-05-12
Shenzhen Xft Medical Limited 2 0 2021-07-08
Shenzhen Dongdixin Technology Co., Ltd. 1 0 2022-02-25
PAJUNK GmbH Medizintechnologie 1 0 2023-11-24
El.En S.P.A. 1 0 2023-09-01
Timewaver Production GmbH 1 0 2021-12-14
Trainfes 1 0 2025-02-05
Rehabtronics, Inc. 1 0 2021-05-13
Egzotech Sp. Z O. O. 1 0 2021-10-01
Enraf-Nonius, B.V. 1 1 2025-09-12
Ibramed Equipamentos Medicos 1 0 2021-05-11
Emsi, Inc. 1 0 2022-10-21
Storz Medical AG 1 0 2021-05-03
Zynex Medical, Inc. 1 0 2024-01-26
Remed Co., Ltd. 1 0 2021-05-06
G.Tec Medical Engineering GmbH 1 0 2020-10-29
Myoworx, Inc. 1 0 2021-10-19
Swims America Corp 1 0 2023-09-14
Medline Industries, Inc. 1 0 2020-09-21
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.

CodeTypeDescriptionConfidenceRationale
97032 CPT Medium CPT for therapeutic procedure with electrical stimulation for muscle
E1600 HCPCS Delivery and/or installation charges for hemodialysis equipment ✓ CMS-verified description Medium HCPCS code for electrical muscle stimulation device
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-08 K253542 Weero Co., Ltd. Apollo Quattro (APQ-10M)
2026-06-02 K252816 Mohammadali Nezakati High Tone Power therapy (HiToP) (Model: HiToP PNP)
2026-05-27 K260142 Motion Informatics ltd. StimelMD (SSMD) system
2025-09-12 K251083 Enraf-Nonius, B.V. Compact II
2025-06-04 K241433 Weero Co., Ltd. EVE Synergy (EVE-20M)
2025-02-05 K241488 Trainfes TrainFES Advance
2024-12-19 K240348 Quantumtx Pte. , Ltd. Quantum Mitohormesis (QMT) (M2101)
2024-10-10 K240992 Weero Co., Ltd. eMVFit (MVF-10M)
2024-08-17 K240234 BTL Industries, Inc. BTL-899MS
2024-08-02 K233098 Sunmed, LLC MYOTouch Muscle Stimulator
2024-05-16 K232786 Edan Instruments, Inc. Stimulation System (PA series, PR series, S series and Q series)
2024-03-21 K233926 Mettler Electronics Corporation accufit
2024-01-26 K233485 Zynex Medical, Inc. M-Wave
2023-12-26 K232937 BTL Industries, Inc. BTL-899M
2023-11-24 K230701 PAJUNK GmbH Medizintechnologie Stim2Go
2023-11-03 K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device
2023-10-10 K223027 Neurotrigger NeuroTrigger Basic (NTB)
2023-10-06 K223802 Mettler Electronics Corporation accufit
2023-09-29 K221274 Fotona D.O.O. StarFormer, TightWave
2023-09-14 K230167 Swims America Corp BACK 4
2023-09-01 K232334 El.En S.P.A. DEKA SIMON
2023-01-17 K213655 Hilltek, LLC HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
2022-10-21 K222201 Medlander Medical Technology, Inc. Biological Feedback and Stimulation System
2022-10-21 K221958 Emsi, Inc. Flex-MI
2022-10-14 K220994 Ncs Lab Srl Shoulder PacemakerTM