Chrysalis Intelligence · Product Codes · BYI

BYI · Percussor, Powered-Electric

Anesthesiology · 8 clearances · 8 unique sponsors

Device class
Class II
Regulation 868.5665
Total clearances
8
2021-01-15 → 2026-04-30
Last 12 months
2
Unique sponsors
8
Medical specialty
Anesthesiology
Review panel
AN
Regulation number
868.5665
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
Synchrony Medical , Ltd. 1 0 2024-12-19
Tactile Medical 1 1 2026-04-30
Electromed, Inc. 1 0 2022-11-18
Exemplar Medical, LLC 1 1 2025-10-02
Baxter Healthcare Corportation 1 0 2024-03-22
Airphysio Pty, Ltd. 1 0 2021-01-15
Chongqing Moffy Innovation Technology Co., Ltd. 1 0 2024-12-18
Med Systems, Inc. 1 0 2021-02-12
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
E0747 HCPCS Osteogenesis stimulator, electrical, non-invasive, other than spinal applications ✓ CMS-verified description Medium Powered percussion vests/percussors for airway clearance DME code
97161 CPT Low Physical therapy evaluation; percussion used in respiratory therapy adjunctively
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-30 K252849 Tactile Medical AffloVest® Mobile Airway Clearance Therapy
2025-10-02 K250860 Exemplar Medical, LLC BreatheBand® (Model 1000)
2024-12-19 K242063 Synchrony Medical , Ltd. LibAirty Airway Clearance System
2024-12-18 K240959 Chongqing Moffy Innovation Technology Co., Ltd. Respiratory Muscle Trainer
2024-03-22 K233441 Baxter Healthcare Corportation The Vest APX System (PVAPX1)
2022-11-18 K222496 Electromed, Inc. Electromed SmartVest Airway Clearance System
2021-02-12 K201490 Med Systems, Inc. Electro Flo 6 Airway Clearance System
2021-01-15 K203209 Airphysio Pty, Ltd. AirPhysio Positive Expiratory Pressure (PEP) Device