Battle Creek Equipment
Fremont, IN, US
Battle Creek Equipment appears in FDA device records in Fremont, IN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Battle Creek Equipment between 1979 and 1988. The busiest year on record is 1985, with 3. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 1 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K882264 | BATTLE CREEK PILLOW | IQK | Substantially Equivalent | |
| K863884 | PULSESTAR EXERCISE BIKE | ISD | Substantially Equivalent | |
| K854147 | BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL | IOL | Substantially Equivalent | |
| K854148 | BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL | IOL | Substantially Equivalent | |
| K851237 | THERMOPHORE ELECTRIC FOMENTATION UNIT | IRT | Substantially Equivalent | |
| K840280 | ROAD RUNNER ELECTRIC TREADMILL | IOL | Substantially Equivalent | |
| K791866 | STANDARD HEALTH BIKE MODEL 019 | ISD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1832415 | 1833125 | Battle Creek Equipment | 702 S Reed Rd, Fremont, IN 46737 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0349-2017 | Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Model 077 Petite 4"x 17",Model 095: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 095 Large 14" x 27 Model 096: Thermophore Classic, Professional Quality Deep-Heat therapy Model 096, Medium, 14" x 14" Model 097: Thermophore Classic, Professional quality Deep-Heat Therapy, Model 097 , Petite, 4" x 17", Model 255: Thermophore Classic Plus, Professional Quality Deep-Heat Therapy, Model 255 Large,14" x 27", Model 256: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 256, Medium, 14" X 14 Model 277: Thermophore Classic Plus Professional Quality Deep-Heat Therapy, Model 277, Petite , 4" x 17" Used for the temporary relief of joint and muscle pain. | Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain