Chrysalis Intelligence · Product Codes · IMI

IMI · Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Physical Medicine · 5 clearances · 4 unique sponsors

Device class
Class II
Regulation 890.5300
Total clearances
5
2021-12-23 → 2025-06-04
Last 12 months
0
Unique sponsors
4
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
Manamed, Inc. 2 0 2023-03-08
Enraf-Nonius, B.V. 1 0 2023-10-24
Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto 1 0 2021-12-23
Jkh Health Co., Ltd. 1 0 2025-06-04
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
97035 CPT High CPT for ultrasonic diathermy therapeutic procedure with deep heat
E1602 HCPCS Medium HCPCS for ultrasonic diathermy equipment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-06-04 K240788 Jkh Health Co., Ltd. Ultrasound Stimulator
2023-10-24 K230472 Enraf-Nonius, B.V. Sonopuls 190
2023-03-08 K222098 Manamed, Inc. ManaSport+
2022-04-26 K210284 Manamed, Inc. ManaSport
2021-12-23 K202788 Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto Sonomed IV, Sonomed V