HealthyLine SOFT4024
HealthyLine SOFT4024 is an electric pad localized-body heating system (FDA Class II; FDA product code IRT, Pad, Heating, Powered) made by Imedia Ny Inc, listed in FDA GUDID since 31 Dec 2024 (UDI-DI B905SOFT40240), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB905SOFT40240 | Date31 Dec 2024 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- HealthyLine
- Generic name
- Electric pad localized-body heating system
- Model / reference
- SOFT4024
- Primary DI / UDI-DI
- B905SOFT40240
- FDA product code
- IRT
- GMDN term
- Electric pad localized-body heating system
- Device class
- Class II
- Regulation number
- 890.5740
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IRT (Pad, Heating, Powered).
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- FORMOSTAR by Lmv, Liske & Methling, GmbH
- HYDRO-THERO PAD by Maddak, Inc.
- bite away neo by mibeTec GmbH
- HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 by Sunbeam Health Division
- THERMAL CONDITIONING SYSTEM by Acurex Aerotherm
- DELUXE HEAT WRAP/COLD WRAP by The Gillette Company
- THERMO-BODY-WRAP SYSTEM by Thermo Body Wrap Systems, Inc.
- MY MASK-E/M250N by ESPANSIONE MARKETING SPA
- PES HOT/COLD COMPRESS by Princeton Electronic Systems, Inc.