Scale-Tronix 48, 2001, 2009, 2700, 3003, 4004, 4800, 5005, 5700, 6005, 6500, 6700, 6006C & 20009, Model N661WC

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K012229 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Replacement Batteries/Welch Allyn #72200 Power Handle

  Class I

  CE/MDR FDA 510(k) K942244 Active Cleared 24 Jun 1994

• Replacement Batteries

  Class I

  FDA 510(k) K943632 Active Cleared 4 Nov 1994

• Baxter AS40A, AS41 Syringe Pump, Model N61WC

  Class II

  FDA 510(k) K012262 Active Cleared 12 Sep 2001

• Nce Replacement Batteries

  Class I

  FDA 510(k) K943680 Active Cleared 4 Nov 1994

• Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10

  Class III

  FDA 510(k) K934067 Active Cleared 7 Oct 1993

• Marquette MAC8, Mac Personal, Mac Stress, Model N3043IWC

  Class II

  FDA 510(k) K012264 Active Cleared 10 Oct 2001

See all devices from National Custom Ent., Inc. →

• What is the Scale-Tronix N661WC battery pack used for?

  The Scale-Tronix N661WC battery pack is designed as a replacement power source for Scale-Tronix infant radiant warmers. These warmers are used in clinical settings to maintain neonatal thermal regulation, and the battery pack provides the electrical power required for their continuous operation. It is specifically intended for aftermarket use, allowing biomedical equipment technicians or end-users to replace depleted batteries in compatible Scale-Tronix models.

• Is the Scale-Tronix N661WC battery pack sterile?

  No, the Scale-Tronix N661WC battery pack is not sterile. It is supplied as a reusable component, meaning it is intended for repeated use after proper maintenance and cleaning. Sterility is not required for this type of replacement battery pack, as it is not directly involved in patient contact beyond the clinical environment where the warmer is used.

• Which Scale-Tronix models is the N661WC battery pack compatible with?

  The Scale-Tronix N661WC battery pack is compatible with a range of Scale-Tronix infant radiant warmer models, including the 48, 2001, 2009, 2700, 3003, 4004, 4800, 5005, 5700, 6005, 6500, 6700, 6006C, and 20009. It is designed as an aftermarket replacement to ensure these specific models continue to function properly by providing the necessary electrical power.

• How should the Scale-Tronix N661WC battery pack be stored?

  The Scale-Tronix N661WC battery pack does not require special storage conditions beyond those recommended for standard medical batteries. It is a reusable component, so it should be stored in a clean, dry environment, away from extreme temperatures or moisture. Proper storage ensures longevity and reliable performance when needed for replacement in compatible Scale-Tronix warmers.

• What regulatory clearance does the Scale-Tronix N661WC battery pack have?

  The Scale-Tronix N661WC battery pack holds an FDA 510(k) clearance under the General Hospital advisory committee, with the clearance number K012229. This classification confirms that the device is substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness as a Class II medical device under regulation 880.5130.