Chrysalis Intelligence · Product Codes · ISA

ISA · Massager, Therapeutic, Electric

Physical Medicine · 7 clearances · 7 unique sponsors

Device class
Class I
Regulation 890.5660
Total clearances
7
2021-05-05 → 2025-02-06
Last 12 months
0
Unique sponsors
7
Medical specialty
Physical Medicine
Review panel
PM
Regulation number
890.5660
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
E.M.S Electro Medical Systems S.A 1 0 2022-07-11
Tissue Regeneration Technologies, LLC 1 0 2021-05-05
Termosalud 1 0 2025-02-06
Tissue Regeneration Technologies, LLC Dba AS Softwave Trt 1 0 2022-10-12
BTL Industries, Inc. 1 0 2023-04-14
Medispec, Ltd. 1 0 2023-01-27
Shenzhen Dongdixin Technology Co., Ltd. 1 0 2024-06-05
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
E0191 HCPCS Heel or elbow protector, each ✓ CMS-verified description High HCPCS code for powered therapeutic massager device
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-02-06 K243488 Termosalud VMAT PRO
2024-06-05 K240358 Shenzhen Dongdixin Technology Co., Ltd. ShockPhysio Mobile (model SW3200 Basic)
2023-04-14 K221865 BTL Industries, Inc. BTL-094
2023-01-27 K210166 Medispec, Ltd. Omnispec ED1000
2022-10-12 K213120 Tissue Regeneration Technologies, LLC Dba AS Softwave Trt OW100S (model OW100S-US)
2022-07-11 K220538 E.M.S Electro Medical Systems S.A DolorClast Radial
2021-05-05 K210451 Tissue Regeneration Technologies, LLC OrthoGold 100