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FDA 510(k)

SPECTRASTIM TM 1000

K-Number: K893964 · 1989-10-06

ApplicantTherapeutic Technologies, Inc.
Decision Date1989-10-06
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPECTRASTIM TM 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Therapeutic Technologies, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K893964. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRASTIM TM 1000?

SPECTRASTIM TM 1000 is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Therapeutic Technologies, Inc.. The 510(k) number is K893964.

When did SPECTRASTIM TM 1000 receive FDA 510(k) clearance?

SPECTRASTIM TM 1000 received FDA 510(k) clearance on 1989-10-06, under 510(k) number K893964.

Who is the listed applicant for SPECTRASTIM TM 1000?

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

What is the FDA product code for SPECTRASTIM TM 1000?

The FDA product code for SPECTRASTIM TM 1000 is IPF.

Related Clinical Trials

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.

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Other records listing Therapeutic Technologies, Inc. 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.

K093705FUORECAMK900029SPECTRASTIM 2000 MUSCLE STIMULATORK854277NEUROPATH 4000K841112TTI REHABILATATION GYM SYS

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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