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FDA 510(k)

ULTRALITE HF1236 HAND AND FOOT SYSTEM

K-Number: K861963 · 1986-06-25

ApplicantUltralite
Decision Date1986-06-25
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRALITE HF1236 HAND AND FOOT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ultralite. It received FDA 510(k) clearance on 1986-06-25 under 510(k) number K861963. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRALITE HF1236 HAND AND FOOT SYSTEM?

ULTRALITE HF1236 HAND AND FOOT SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-25. The listed applicant is Ultralite. The 510(k) number is K861963.

When did ULTRALITE HF1236 HAND AND FOOT SYSTEM receive FDA 510(k) clearance?

ULTRALITE HF1236 HAND AND FOOT SYSTEM received FDA 510(k) clearance on 1986-06-25, under 510(k) number K861963.

Who is the listed applicant for ULTRALITE HF1236 HAND AND FOOT SYSTEM?

The FDA 510(k) record lists Ultralite as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRALITE HF1236 HAND AND FOOT SYSTEM?

The FDA product code for ULTRALITE HF1236 HAND AND FOOT SYSTEM is FTC.

Related Clinical Trials

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Other records listing Ultralite as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K910091ULTRALITE PANELITEK820492SPECTRA305K820280SPECTRA 305/350K827123SPECTRA (ULTRAVIOLET PRODUCTS)K761179PSORALITE

Related Devices (Code: FTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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