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
Jkh Health Co., Ltd. 1 0 2025-06-04
Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto 1 0 2021-12-23
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
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