Chrysalis Intelligence · Product Codes · PZL

PZL · Unclassified

6 clearances · 5 unique sponsors

Device class
Regulation —
Total clearances
6
2020-08-28 → 2025-08-13
Last 12 months
0
Unique sponsors
5
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Softwave/Trt, LLC 2 0 2024-07-09
Curative Sound Therapeutics 1 0 2025-07-02
Storz Medical AG 1 0 2021-02-21
Tissue Regeneration Technologies, LLC 1 0 2020-08-28
E.M.S Electro Medical Systems S.A 1 0 2025-08-13
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
28890 CPT Medium CPT for extracorporeal shock wave therapy, lower extremity
97610 CPT Medium CPT for low frequency, non-contact normothermic wound therapy
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-08-13 K243279 E.M.S Electro Medical Systems S.A DOLORCLAST Focused Shock Waves
2025-07-02 K250779 Curative Sound Therapeutics CS-Pro MED
2024-07-09 K233937 Softwave/Trt, LLC OW100S
2023-09-01 K231710 Softwave/Trt, LLC OW100S
2021-02-21 K202112 Storz Medical AG Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
2020-08-28 K200926 Tissue Regeneration Technologies, LLC OrthoGold 100