Chrysalis Intelligence · Product Codes · PFW

PFW · Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Physical Medicine · 6 clearances · 2 unique sponsors

Device class
Class II
Regulation 890.5300
Total clearances
6
2020-03-06 → 2026-04-28
Last 12 months
1
Unique sponsors
2
Definition

What is Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Medical specialty
Physical Medicine
Review panel
PM
Regulation number
890.5300
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
ZetrOZ Systems, LLC 5 1 2026-04-28
Nanovibronix, Inc. 1 0 2022-11-23
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 High Therapeutic procedures, ultrasound; standard code for therapeutic ultrasound diathermy
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-28 K260076 ZetrOZ Systems, LLC SAM 3.0 Multi-Hour Continuous Ultrasound Device
2023-10-25 K233210 ZetrOZ Systems, LLC sam CS Long Duration Ultrasound Device
2023-06-23 K223019 ZetrOZ Systems, LLC sam 2.0 Long Ultrasound Device
2022-11-23 K221210 Nanovibronix, Inc. PainShield MD PLUS
2021-08-18 K211513 ZetrOZ Systems, LLC sam X1 Long Duration Ultrasound Device
2020-03-06 K191568 ZetrOZ Systems, LLC sam 2.0 Long Duration Ultrasound System