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Sign in to claim this brandPhysician Engineered Products, Inc.
US
Last updated May 30, 2026
What Physician Engineered Products, Inc. makes
Physician Engineered Products, Inc. manufactures medical devices for neonatal phototherapy, including overhead units designed to treat jaundice in infants, such as the Ultra Bili Light and Institutional Bili Light. The company also produces accessories like the Retrofit Baby Face Shield and Bili-Mirror Model BLM-1, as well as specialized equipment for resuscitation, including the Resuscitation Bag Controller. Additional products include home-use phototherapy devices like the Home Bili Lights Model 100 and Bright Embrace Model SBL60, along with a modified reflux reducer for pediatric use.
The company’s devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. These products are listed in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- peponline.com
- —
- —
- [email protected]
- Phone
- 1-800-622-6240
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 144657848
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ultra Bili Light | 2000 | FDA UDI | Class II | Active |
| Retrofit Baby Face Shield (rfs) | K882291 | FDA 510(k) | Class II | Active |
| Institutional Bili Light (ibl) | K873700 | FDA 510(k) | Class II | Active |
| Resuscitation Bag Controller (rbc) | K882278 | FDA 510(k) | Class II | Active |
| Home Bili Lights-Model 100 | K850599 | FDA 510(k) | Class II | Active |
| Bright Embrace Model Sbl60 | K110550 | FDA 510(k) | Class II | Active |
| Modified Reflux Reducer | K883818 | FDA 510(k) | Class II | Active |
| Ultra Bili Light | K974830 | FDA 510(k) | Class II | Active |
| Bili-Mirror Model Blm-1 | K093618 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Physician Engineered Products, Inc. has one FDA recall record initiated on 2013-08-31, which is listed with a terminated status. The recall was due to an incorrect upper limit for ambient temperature being printed in the device’s instructions.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 31, 2013 | Z-2486-2015 | — | terminated | Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions |