Firard II/ Tdp Lamp
by Helio Medical Supplies, Inc.
510(k) K960036
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960036 | Date6 Jun 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ILY
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Firard II/TDP Lamp is an infrared lamp classified under the FDA’s Infrared Lamp category (product code ILY), designed to emit energy in the infrared spectrum (approximately 700 nm to 50,000 nm) for topical heating applications. It falls under the Physical Medicine device type and is intended for medical use in controlled thermal therapy.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as physical therapy or rehabilitation. It has received FDA 510(k) clearance under the Traditional pathway, with a clearance date of June 6, 1996. No specific sterility or MRI safety information is provided in the regulatory data, and no additional size or storage specifications are noted beyond its classification as a therapeutic heating lamp.
Other devices from Helio Medical Supplies, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Firard II/TDP Lamp in clinical settings?
The Firard II/TDP Lamp is designed for topical heating applications under controlled thermal therapy, falling under the category of physical medicine devices. It emits infrared energy (approximately 700 nm to 50,000 nm) to provide localized warmth, commonly used in physical therapy or rehabilitation to promote relaxation, reduce muscle stiffness, or improve circulation.
Is the Firard II/TDP Lamp intended for single-use or reusable in a clinical environment?
The device is explicitly labeled as a reusable medical instrument, meaning it is meant for repeated use in clinical settings like physical therapy or rehabilitation. There are no indications in the regulatory data regarding sterilization requirements or MRI safety, so proper cleaning and maintenance protocols should be followed as per facility guidelines.
How was the Firard II/TDP Lamp evaluated by the FDA, and what does that mean for its use?
The device received FDA 510(k) clearance under the Traditional pathway in June 1996, with a determination of substantially equivalent to a legally marketed predicate. This means the FDA reviewed it against existing infrared lamps and found it to meet safety and effectiveness standards for topical heating applications in physical medicine, though it does not imply any specific clinical indication beyond what is described in the regulatory data.
Are there any special storage requirements for the Firard II/TDP Lamp mentioned in the regulatory data?
The regulatory data does not specify any particular storage conditions beyond its classification as a therapeutic heating lamp. However, since it is reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality and ensure longevity. Always follow manufacturer recommendations for optimal care.