Identity
- Trade Name
- Bashan FDA UDI
- Generic Name
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
- Device Name
- Bashan TDP Heat Lamp, including TDP-124D/166D and TDP-124F/166F, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help minor muscular back pain. FDA UDI
- Model / Reference
- TDP-124D,TDP-166D FDA UDI
- Description
- Bashan TDP Heat Lamp, including TDP-124D/166D and TDP-124F/166F, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help minor muscular back pain. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970567470162 FDA UDI
- 510(k) Number
- K162590 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Musculoskeletal infrared phototherapy unit, non-wearable
Bashan by Chongqing Yuhe Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MiS US — ASA SRL · Class II
Cleared under the same submission
K162590 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Chongqing Yuhe Medical Instruments Co., Ltd.
Sources (1)
- FDA UDI 7905ec05-0d0f-4c35-b28f-1f0283eb46e7 34 fields · synced May 30, 2026