Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBattle Creek Equipment Co.
US
Last updated May 25, 2026
What Battle Creek Equipment Co. makes
Battle Creek Equipment Co. manufactures electric pad systems designed for localized-body heating, including reusable and customizable models for therapeutic or comfort applications. Products include wrap-style devices like the Embrace™ Relief Wrap and modular heating pads such as the Thermophore series, with variations like the Max Heat Thermophore and Thermophore Deluxe. The Custom Touch line offers tailored heating solutions for specific user needs.
The company’s devices are regulated under FDA classifications, with most falling into Class I or Class II. Authorisation records appear in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer is based in the United States.
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 Battle Creek Equipment Co. manufacture?
Battle Creek Equipment Co. specializes in electric pad systems designed for localized-body heating. Their products include reusable and customizable heating devices, such as wrap-style systems like the Embrace™ Relief Wrap and modular heating pads like the Thermophore series. These devices are primarily used for therapeutic or comfort applications, with variations like the Max Heat Thermophore and Thermophore Deluxe to cater to different user needs.
Where is Battle Creek Equipment Co. based?
Battle Creek Equipment Co. is headquartered in the United States. The company’s location influences its regulatory compliance with U.S. medical device standards, including those enforced by the FDA.
Which regulatory databases list Battle Creek Equipment Co.’s devices?
Battle Creek Equipment Co.’s devices are recorded in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track authorised devices under U.S. medical device regulations, ensuring transparency for healthcare providers and regulators.
How are Battle Creek Equipment Co.’s devices classified under FDA regulations?
Battle Creek Equipment Co.’s devices are primarily classified as Class I or Class II under FDA guidelines. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorisation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 001957422
Catalogue (72)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Embrace™ Relief Wrap | Knee | FDA UDI | Class II | Active |
| Muff | F00174 | FDA UDI | Class II | Active |
| Max Heat Thermophore | F00355 | FDA UDI | Class II | Active |
| Embrace™ Relief Wrap | Back | FDA UDI | Class II | Active |
| Custom Touch | F00810 | FDA UDI | Class II | Active |
| Thermophore Deluxe | F00247 | FDA UDI | Class II | Active |
| Max Heat Thermophore | F00155 | FDA UDI | Class II | Active |
| Thermophore Freedom | F00225 | FDA UDI | Class II | Active |
| Thermophore Sport | F00286 | FDA UDI | Class II | Active |
| Thermophore | F33156 | FDA UDI | Class II | Active |
| Max Heat Thermophore | F20156 | FDA UDI | Class II | Active |
| Thermophore | F33155 | FDA UDI | Class II | Active |
| Embrace™ Relief Wrap | Neck | FDA UDI | Class II | Active |
| Thermophore Freedom | F00235 | FDA UDI | Class II | Active |
| Bed Warmer | F00058 | FDA UDI | Class II | Active |
| Standard Health Bike Model 019 | K791866 | FDA 510(k) | Class II | Active |
| Battle Creek Pillow | K882264 | FDA 510(k) | Class I | Active |
| Battle Creek Digi-Tracker Elctric Treadmill | K854148 | FDA 510(k) | Class I | Active |
| Pulsestar Exercise Bike | K863884 | FDA 510(k) | Class II | Active |
| Battle Creek Boardwalker Electric Treadmill | K854147 | FDA 510(k) | Class I | Active |
| Road Runner Electric Treadmill | K840280 | FDA 510(k) | Class I | Active |
| Thermophore Electric Fomentation Unit | K851237 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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.
Battle Creek Equipment Co. has one FDA recall record initiated on 2016-09-15, which is listed with a terminated status. The recall pertains to products manufactured with the SPT cord, where the filed reason states a known failure mode involving sparking, potentially causing smoke, fire, and burns.
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 |
|---|---|---|---|---|
| Sep 15, 2016 | Z-0349-2017 | — | terminated | Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns. |