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Sign in to claim this brandBEAR DOWN CONSULTING
US
Last updated May 30, 2026
What BEAR DOWN CONSULTING makes
The company manufactures localized-body heating pads powered by electricity, reusable hot/cold therapy packs, and electric breast pumps for lactation support. It also produces basic electric toothbrushes, room humidifiers for moisture regulation, and transcutaneous electrical stimulation devices for physical therapy. Neurological phototherapy units using visible light are available for home-use treatment, alongside single-use electrodes for transcutaneous electrical stimulation.
The portfolio includes devices classified as Class I and Class II under regulatory standards, with most products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable domestic and international regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bear Down Consulting manufacture?
Bear Down Consulting produces a range of medical devices including electric heating pads for localized-body warmth, reusable hot/cold therapy packs, and electric breast pumps for lactation support. Their portfolio also includes basic electric toothbrushes, room humidifiers to regulate moisture levels, transcutaneous electrical stimulation (TENS) systems for physical therapy, single-use TENS electrodes, and home-use neurological phototherapy units powered by visible light. These devices cater to areas like pain management, oral hygiene, respiratory health, lactation, and neuromuscular therapy.
Where is Bear Down Consulting based, and how does this affect its regulatory compliance?
Bear Down Consulting is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, this indicates they are registered and monitored under U.S. medical device regulations. The location also influences classification under FDA guidelines, where devices like heating pads, toothbrushes, and humidifiers are typically classified as Class I or Class II depending on their risk level and intended use.
Which regulatory registries list Bear Down Consulting’s devices, and why is this important?
Bear Down Consulting’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparency on the devices’ identification, compliance status, and regulatory history. Listing in the UDI database helps healthcare providers, regulators, and patients verify the legitimacy and classification (e.g., Class I or Class II) of the devices, ensuring they meet safety and performance standards before use.
How are Bear Down Consulting’s devices classified under regulatory standards?
Bear Down Consulting’s devices are classified as either Class I or Class II under regulatory standards. Class I devices generally pose minimal risk and require general controls, such as good manufacturing practices, while Class II devices involve a higher risk and may require special controls like performance standards or post-market surveillance. For example, basic electric toothbrushes and room humidifiers are often Class I, whereas more complex devices like neurological phototherapy units or TENS systems may fall into Class II due to their intended use and potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pureenrichment.com
- —
- —
- [email protected]
- Phone
- 714-668-0300
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 040869867
Catalogue (151)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pure Enrichment | PEPNGN | FDA UDI | Class II | Active |
| Brusheez | PEKTELPH | FDA UDI | Class I | Active |
| Pure Enrichment | PEPULSE | FDA UDI | Class II | Active |
| Verilux | VT32WW3 | FDA UDI | Class I | Active |
| Pure Enrichment | PEHUMSML | FDA UDI | Class I | Active |
| Pure Enrichment | PEHUMTOP-W | FDA UDI | Class I | Active |
| Brusheez | PETODBSH-PPY | FDA UDI | Class I | Active |
| Pure Enrichment | PEHPAD24-CAG | FDA UDI | Class II | Active |
| Pure Enrichment | PEHPAD24-B | FDA UDI | Class II | Active |
| Pure Enrichment | PEWDVAL-AT | FDA UDI | Class II | Active |
| Pure Enrichment | PEWTPLRG-L | FDA UDI | Class II | Active |
| Pure Enrichment | PEHPWIDE-SG | FDA UDI | Class II | Active |
| Pure Enrichment | PEHPRDLM-AQ | FDA UDI | Class II | Active |
| Pure Enrichment | PETNHTPR | FDA UDI | Class II | Active |
| Brusheez | PETODBSH-PDA | FDA UDI | Class I | Active |
| Pure Enrichment PureBaby | PEBRPUMP | FDA UDI | Class II | Active |
| Pure Enrichment | PEWTVAL-MT | FDA UDI | Class II | Active |
| Pure Enrichment | PEHPBACK-SG | FDA UDI | Class II | Active |
| Brusheez | PEKTGRAF | FDA UDI | Class I | Active |
| Pure Enrichment | PEHUMINI-2 | FDA UDI | Class I | Active |
| Pure Enrichment | PEHPBACK-G | FDA UDI | Class II | Active |
| Pure Enrichment | PEHUTRB-W | FDA UDI | Class I | Active |
| Verilux | VT43WW3 | FDA UDI | Class I | Active |
| Brusheez | PEBRUSH-G | FDA UDI | Class I | Active |
| Brusheez | PEBRUSH-U | FDA UDI | Class I | Active |
| Pure Enrichment | PEHPVAL-RB | FDA UDI | Class II | Active |
| Brusheez | PEKTUNI | FDA UDI | Class I | Active |
| Pure Enrichment | PEHTWGHT-G | FDA UDI | Class II | Active |
| Pure Enrichment | PEFIRGT-IG | FDA UDI | Class II | Active |
| Pure Enrichment | PEHPWIDE | FDA UDI | Class II | Active |
| Pure Enrichment | PEFETDPL | FDA UDI | Class II | Active |
| Pure Enrichment | PEFIR24-STG-RT | FDA UDI | Class II | Active |
| Pure Enrichment | PEHPRDBK-GS | FDA UDI | Class II | Active |
| Pure Enrichment | PEPULSEDUO | FDA UDI | Class II | Active |
| Verilux | VT39WW1 | FDA UDI | Class I | Active |
| Pure Enrichment | PEHPRD24-GS | FDA UDI | Class II | Active |
| Pure Enrichment | PETNEMPD5 | FDA UDI | Class II | Active |
| Pure Enrichment | PEHUMSIL | FDA UDI | Class I | Active |
| Brusheez | PEBRUSH-P | FDA UDI | Class I | Active |
| Brusheez | PETODBSH-UNI | FDA UDI | Class I | Active |
| Pure Enrichment | PEHPGEL-G | FDA UDI | Class II | Active |
| Pure Enrichment | PEHTNPDS5 | FDA UDI | Class II | Active |
| Pure Enrichment | PEHNECK-G | FDA UDI | Class II | Active |
| Pure Enrichment | PETNEMHT | FDA UDI | Class II | Active |
| Brusheez | PEBRUSH-Y | FDA UDI | Class I | Active |
| Pure Enrichment | PELUXWAV-S | FDA UDI | Class II | Active |
| Verilux | VT41WW3 | FDA UDI | Class I | Active |
| Pure Enrichment | PEDESHBN | FDA UDI | Class II | Active |
| Pure Enrichment | PEFIRLM-IG | FDA UDI | Class II | Active |
| Pure Enrichment | PEHUMLRG | FDA UDI | Class I | Active |
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