Summary
Whitehall’s current product page lists WHE-15-M as in stock and describes clinical extremity use. Manufacturer whirlpool documentation specifies professional healthcare and supervised athletic-training use. Clinical benefit statements are manufacturer labeling rather than an independent effectiveness assessment. [5][6]
Device records identify Whitehall Manufacturing Co as labeler of Thermasplint SP-1600-D, a water bath for warming splint and orthotic materials. It reports commercial distribution, product code IRQ and premarket exemption. That record does not establish current availability from Whitehall’s current storefront or apply to the whirlpool family. [1]
FDA records a March 24, 1995 clearance, K950350, for specified Thermalator heating-unit models. The applicant is recorded as Whitehall/Div Columbus Mckennon Corp. The historical legal-name relationship and mapping to current marketed models require verification; this decision is excluded from current-portfolio counts. [2]
Plumbing certifications or manufacturer licensing should not be described as FDA product clearance.